header advert
Results 1 - 100 of 692
Results per page:
The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 705 - 712
1 Jul 2024
Karlsson T Försth P Öhagen P Michaëlsson K Sandén B

Aims

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences.

Methods

The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 254 - 255
1 May 2009
Goel D Abelseth G Buckley R deVries G Fick G Gray R Ni A
Full Access

The incidence of DVT and need for thrombo-prophylaxis following isolated distal lower extremity fractures is unknown. The purpose of this study was to determine whether or not thrombo-prophylaxis with low molecular weight heparin was needed in this trauma population. A Multicentered Prospective Randomised Double Blind Placebo Controlled Trial was designed to define the incidence of DVT and need for thrombo-prophylaxis in this population. A sample size of two hundred and ninety-nine patients ensured a one tailed type one error of alpha = 0.05 and power of 80% as confirmed from previous studies. Males and female patients between the ages of eighteen and seventy-five years with isolated distal lower extremity fractures (excluding the foot) were eligible. All patients had surgery within forty-eight hours after injury. Patients excluded from the trial were polytrauma patients, those medically unfit for the operating room, patients with foot fractures, those receiving anticoagulation, inability to provide consent, platelets 200 umol /L. Randomization was carried out via computer generation to receive either placebo or Fragmin for fourteen days. At fourteen days, all patients underwent bilateral venograms interpreted by three independent radiologists. Equivocal venograms were interpreted by consensus. Routine follow-up was carried out for all patients at two, six, eight and twelve weeks. A total of two hundred and ninety-nine patients were enrolled in the study. One hundred thirty-six patients in the Fragmin group and one hundred and twentyfive in the placebo group completed the intervention. There were one hundred and twenty-five males and one hundred and thirty-six females in total. There was no statistically significant difference in DVT incidence between those patients treated with Fragmin or Placebo (p = 0.41). Gender, medical issues, pre-operative level of activity and body mass index had no effect on the incidence of DVT. The incidence of DVT in fragmin treated and placebo treated patients is 8.1% and 11.2%, respectively (p = 0.41). This study suggests that DVT thrombo-prophylaxis is not indicated in this patient population. To our knowledge, this is the first Randomised Controlled Trial utilizing venograms (gold standard) for DVT identification


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_3 | Pages 12 - 12
1 Feb 2014
Munro C Johnstone A
Full Access

This prospective Randomised Controlled Trial compared two surgical approaches with respect to accuracy of guidewire and tibial nail position. Sixty-seven patients with tibial fractures were randomised to semi-extended (SE) or standard (S) approaches of nail insertion. Fluoroscopy was performed at guidewire insertion and final nail position. The SE approach is more proximal with the guidewire inserted posterior to the patella, theoretically allowing a better angle for more accurate nail placement. Measurements were taken in the Anteroposterior and lateral planes of both the nail and guidewire to determine deviation from the optimal angle of insertion (relative to the long axes of the tibial shaft). Thirty-nine and twenty-eight patients were treated with semiextended and standard approaches respectively. The semiextended approach resulted in improved nail placement to statistical significance in both planes, with mean deviation from the optimal angle of insertion as below:. Guidewire AP 3.2° (SE) versus 4° (S) Lateral 27.1° (SE) versus 30.2° (S). Nail AP 2.4° (SE) versus 4.2° (S) Lateral 17.9° (SE) versus 21.8° (S). Poor positioning of the guidewire leads to excessive anterior placement of the nail by eccentric reaming. Anterior positioning of the guidewire and nail in the lateral plane was assessed. This was expressed as a percentage from the anterior cortex of the tibia. Guidewire: Lateral 9.7% (SE) versus 9.3% (S). Nail: Lateral 23.4% (SE) 19.3% (S) (p 0.043). Semiextended nailing allows a better angle for guidewire placement and a more optimal final nail position. This facilitates accurate nail placement particularly in difficult proximal third fractures


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 14 - 14
1 Mar 2009
Kapoor A Rafiq I Harvey P Murali R
Full Access

INTRODUCTION: CTS is the most common nerve entrapment syndrome. Repeated flexion and extension activities of the wrist coupled with certain finger flexion causes oedema and compression of the median nerve within the carpal tunnel of the wrist. Several treatment options, both conservative and surgical are available to relieve the pressure on the median nerve. Although studies support the efficacy of splinting for CTS the length of splinting, type of splints, day or night use and the effects on other variables are still less agreed. MATERIALS AND METHODS: A Randomised control trial with subjects randomised to a splint and a control group. 44 patients(60 hands) evaluated at recruitment, 2,8 and 12 weeks. Difference in Levine’s symptom and functional severity scores, between the two groups, used as the primary outcome measure. STATISTICAL METHODS: Repeated measure analysis(ANOVA) and paired t test used for statistical analysis between the two groups. RESULTS: There was no difference between the two groups at baseline. Improvement in symptom severity score in the splinted group at the end of 12 weeks(p< 0.05). No difference in functional severity between the two groups. CONCLUSION: Splintage helps to improve symptoms related to carpal tunnel syndrome in a short term period. This is the duration that the patients referred by GP’s have to wait before seeing a hand specialist. Hence they can be treated with splints during this period to give them symptomatic relief


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 9 - 9
1 Apr 2017
Wylde V Lenguerrand E Gooberman-Hill R Beswick A Marques E Noble S Horwood J Pyke M Dieppe P Blom A
Full Access

Background. Total hip replacement (THR) and total knee replacement (TKR) are usually effective at relieving pain; however, 7–23% of patients experience chronic post-surgical pain. These trials aimed to investigate the effect of local anaesthetic wound infiltration on pain severity at 12 months after primary THR or TKR for osteoarthritis. Methods. Between November 2009 and February 2012, 322 patients listed for THR and 316 listed for TKR were recruited into a single-centre double-blind randomised controlled trial. Participants were randomly assigned (1:1) to receive local anaesthetic infiltration and standard care or standard care alone. Participants and outcomes assessors were masked to group allocation. The primary outcome was pain severity on the WOMAC Pain scale at 12 months post-surgery. Analyses were conducted using intention-to-treat and per-protocol approaches. Ethics approval was obtained from Southampton and South West Hampshire Research Ethics Committee. Results. In the hip trial, patients in the intervention group had significantly less pain at 12 months post-operative than patients in the standard care group (differences in means 4.74; 95% CI 0.95, 8.54; p=0.015), although the difference was not clinically significant. Post-hoc analysis found that patients in the intervention group were more likely to have none to moderate pain than severe pain at 12 months than those in the standard care group (odds ratio 10.19; 95% CI 2.10, 49.55; p=0.004). In the knee trial, there was no strong evidence that the intervention influenced pain severity at 12 months post-operative (difference in means 3.83; 95% CI −0.83, 8.49; p=0.107). Conclusions. In conclusion, routine use of infiltration could be beneficial in improving long-term pain relief for some patients after THR. Level of evidence. Randomised controlled trial. Funding. This article presents independent research funded by the National Institute for Health Research (NIHR) in England under its Programme Grants for Applied Research programme (RP-PG-0407-10070). The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The research team acknowledge the support of the NIHR, through the Comprehensive Clinical Research Network


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 324 - 324
1 Sep 2005
Griffin D
Full Access

Introduction and Aims: Randomised controlled trials (RCTs) are frequently presented as the best design for studies of treatment effect because they minimise bias from unknown confounders. But, very few have been performed in orthopaedic and trauma surgery in comparison to other areas of medicine. This study investigated the perceived obstacles to performing RCTs, in order to identify areas where novel aspects of study design may facilitate randomisation in orthopaedic research. Method: A qualitative study was performed using a deliberate maximum variation sample of 24 orthopaedic surgeons from four countries, involved in all aspects of practice, teaching, research, research funding, ethical approval and publication. A semi-structured interview was used to explore surgeons’ perceptions of obstacles to performing RCTs. A computer-assisted framework approach was used to analyse transcripts of these interviews, and to identify consistent themes and connections between them. Results: Thirty-four discrete obstacles to performing RCTs in trauma and orthopaedic surgery were identified and classified. Many of these fell into six main themes:. A non-evaluative culture;. Misunderstanding of the scientific basis of trial design;. Lack of individual equipoise;. The complexity of the relationship between patient and surgeon;. Inadequate measures of outcome;. Practical problems associated with long follow-up, clinical work load and lack of funding. Conclusion: A complex set of perceived problems were identified. None of these problems is insurmountable. The performance of RCTs would be encouraged by development of a more evaluative culture, collaboration between surgeons and epidemiologists, and greater resources for, and commitment to, clinical research. Novel study designs to address lack of individual equipoise are possible and offer the prospect of much greater use of randomisation


Aims

Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial.

Methods

DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 96 - 96
1 Sep 2012
van Dijck S Young S Patel A Zhu M Bevan W Tomlinson M
Full Access

Acute achilles tendon ruptures are increasing in incidence and occur in 18 per 100 000 people per year, however there remains a lack of consensus on the best treatment of acute ruptures. Randomised studies comparing operative versus non-operative treatment show operative treatment to have a significantly lower re-rupture rate, but these studies have generally used non-weight bearing casts in the non-operative group. Recent series utilizing more aggressive non-operative protocols with early weight-bearing have noted a far lower incidence of re-rupture, with rates approaching those of operative management. Weight bearing casts may also have the advantages of convenience and an earlier return to work, and the purpose of this study was to compare outcomes of traditional casts versus Bohler-iron equipped weight-bearing casts in the treatment of acute Achilles tendon ruptures. 83 patients with acute Achilles tendon ruptures were recruited from three Auckland centres over a 2 year period. Patients were randomised within one week of injury to receive either a weight-bearing cast with a Bohler iron or a traditional non weight-bearing cast. A set treatment protocol was used, with a total cast time of eight weeks. Patients underwent detailed muscle dynamometry testing at 6 months, with further follow up at 1 year and at study completion. Primary outcomes assessed were patient satisfaction, time to return to work, and overall re-rupture rates. Secondary outcomes included return to sports, ankle pain and stiffness, footwear restrictions, and patient satisfaction. There were no significant differences in patient demographics or activity levels prior to treatment. At follow up, 1 patient (2%) in the Bohler iron group and 2 patients (5%) in the non weight bearing group sustained re-ruptures (p=0.62). There was a trend toward an earlier return to work in the weight-bearing group, with 58% versus 43% returning to work within 4 weeks, but the difference was not significant. 63% of patients in the weight bearing group reported freedom from pain at 12 months compared to 51 % in the non weight bearing group. There were no statistically significant differences in Leppilahti scores, patient satisfaction, or return to sports between groups. Weight-bearing casts in the non-operative treatment of Achilles tendon ruptures appear to offer outcomes that are at least equivalent to outcomes of non-weight bearing casts. The overall rerupture rate in this study is low, supporting the continued use of initial non-operative management in the treatment of acute ruptures


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 320 - 320
1 May 2010
Hartwright D smith RC Keogh A Khan R
Full Access

Objectives: To compare the results of various surgical approaches to the knee in primary total knee arthroplasty (TKA) surgery. Design: Systematic review with meta-analysis. Data Sources: Cochrane Bone, Joint, and Muscle Trauma group trials register (2007), Cochrane central register of controlled trials (Cochrane Library issue 2, 2007), Medline (1950–2007), Embase (1974–2007), CINAHL (1982–2007), Pubmed, SCOPUS and ZETOC. Review Methods: Randomised and quasi-randomised controlled trials comparing surgical approaches in patients undergoing primary TKA. Relative risks and 95% CIs were calculated for dichotomous outcomes, and weighted mean differences and 95% CIs calculated for continuous outcomes. Individually randomised trials were pooled whenever possible with the use of the fixed-effects model of Mantel-Haenszel. Results: 53 articles were identified using our search strategy; of these, 32 were excluded from the systematic review. 21 trials involving 1082 patients (1170 TKAs) were included. Midvastus (MV) vs Medial Parapatellar (MPP) approach:. Quadriceps function in the early post operative period was better preserved in the MV group. Post operative pain, blood loss and the need for LRR tended to be lower in the MV group. Subvastus (SV) vs Medial Parapatellar approach:. Quadriceps function was better preserved in the SV group up to 3 months post operatively. ROM was generally greater up until the 4 week time point. Post operative pain and blood loss was lower in the SV group. Midvastus vs Subvastus approach:. The SV group suffered with significantly more pain at six months post operatively. Quadriceps-sparing versus Medial Parapatellar Approach:. Significantly longer operative times and more complications were noted in the QS group. Modified ‘Quadriceps sparing’ Medial Parapatellar vs Mini-Subvastus (MSV) approach:. A tendency for earlier restoration of SLR and better early ROM was noted in the MSV group. Conclusions: Approaches preserving the quadriceps tendon improve the early extensor mechanism function and tend to decrease the need for LRR. Combined with a decrease in blood loss and postoperative pain, these approaches improve early rehabilitation and allow for a more rapid recovery of knee function. However, these early improvements fail to provide any long term benefit, do not improve knee scores, or decrease the length of hospital stay. MIS tends to result in an improved early quadriceps function and decreased blood loss. However, these approaches are technically more demanding, result in longer operative times and provide no long-term benefit. There is concern that they result in a greater number of major complications and risk implant mal-alignment. Eversion of the patella seems to correlate with poor quadriceps function


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 287 - 287
1 May 2006
Memon AR O’Connor PA Kelly I
Full Access

Object: To assess the benefit of prescribed Iron supplementation on the recovery of patient’s Haemoglobin level after elective joint replacement. Design: A Prospective, Randomised Trial was undertaken. All patients undergoing elective arthroplasty (Hip, Knee, and Revision Hip) at our unit were considered. Qualifying parameters included: a normal store of Iron (Fe) prior to surgery (based on the serum Ferrittin level) and normal markers of inflammation (serum C - reactive protein [CRP] and erythrocyte sedimentation rate [ESR]). Elevated CRP and ESR are known to be factors affecting the serum Ferrittin level. Method: 318 patients undergo joint replacement from May 2004 to Oct 2004 were considered for the study. 208 patients were excluded for the following reasons: 52 patients had low serum Ferrittin level or elevated ESR and CRP levels pre-operatively. 156 patients was normal post operative Haemoglobin (> 11 mg %). This left 110 patients with normal pre-operative inflammatory markers and Iron stores. This cohort formed the basis of the study and was randomised to either receiving prescribed Iron Supplementation (Oral Ferrous Sulphate) twice a day for 8 week or no supplementation. Randomisation was performed based on the month of surgery. Even numbered months received the intervention, odd numbered did not. Post-operatively all patients had serum Haemoglobin checked at intervals 2. nd. –7. th. day and 8 weeks. Results: There was no significant different in mean Haemoglobin level between treatment group i.e. 12.72 mg% (10.8–15.4) and controlled group 12.71 mg% (11–15.3) at 8 weeks follow up. Conclusion: The prescription of oral Iron in healthy postoperative joint replacement patients did not hasten the recovery of Haemoglobin level provided adequate tissue Iron stores were present. The use of Fe supplementation provides no benefit in these patients and our study confirms this. Iron supplementation therapy should be reserved for patients identified pre-operatively with either low Iron stores or elevated serum inflammatory markers


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 423 - 423
1 Sep 2009
Hartwright D Keogh A Carey-Smith R Khan RJK
Full Access

Objectives: To compare the results of various surgical approaches to the knee in primary arthroplasty surgery. Design: Systematic review with meta-analysis. Data Sources: Cochrane Bone, Joint, and Muscle Trauma group trials register (2007), Cochrane central register of controlled trials (Cochrane Library issue 2, 2007), Medline (1950 to February 2007), Embase (1974 to February 2007), CINAHL (1982 to February 2007), Pubmed, SCOPUS and ZETOC. If data was insufficient trialists were contacted via telephone, email or letter. Review methods: Randomised and quasi-randomised controlled trials comparing surgical approaches to the knee in patients undergoing primary arthroplasty surgery. Results: Twenty-three randomised, controlled trials (1282 patients, 1490 TKAs) were included. Midvastus vs Medial Parapatellar approach: Quadriceps function in the early post operative period was better preserved in the MV group. Post operative pain, blood loss and the need for LRR tended to be lower in the MV group. There was no difference in ROM, hospital stay, knee scores, complications or radiological alignment. Subvastus vs Medial Parapatellar approach: Quadriceps function was better preserved in the SV group up to 3 months post operatively. ROM was generally greater up to the 4 week time point. Post operative pain and blood loss was lower in the SV group. There was no difference in operative/tourniquet time, hospital stay, rate of LRR, or complications. Modified “Quadriceps sparing” Medial Parapatellar vs Mini-Subvastus (MSV) approach: A tendency for earlier restoration of SLR and better early ROM was noted in the MSV group. Midvastus vs Subvastus approach: The SV group suffered with significantly more pain at six months post operatively. Conclusions: Approaches preserving the quadriceps tendon improve the early extensor mechanism function and tend to decrease the need for LRR. Combined with a decrease blood loss and postoperative pain, these approaches improve early rehabilitation and allow for a more rapid recovery of knee function. However, these early improvements fail to provide any long term benefit, do not improve knee scores, or decrease the length of hospital stay


Randomised controlled trials (RCT) published in the British volume of the JBJS from United Kingdom based institutes have been analysed to review the level of involvement of junior doctors over the past 25 years (1988 to 2012) which included three different training eras: Pre-Calman (1988 to 1995), Calman (1996 to 2006), and MMC (2007 to 2012). Authors were divided into: Senior doctors, Registrars, Fellows, Senior House Officers/ Foundation Doctors, and Others. The level of involvement has been identified as being first author, senior author or co-author. One hundred and fifty nine RCTs have been identified with a total of 705 authors. Eighty eight registrars, 32 fellows and 19 SHO/ Foundation doctors have been involved in RCT published over the last 25 years (19.7%). Registrars constituted 15% of all authors in the pre-Calman, 12% in the Calman and 11% in the MMC periods. They constituted 33% of all first authors in the pre-Calman, 21% in the Calman, and 12% in the MMC periods. With regards to SHO/ Foundation doctors, they were only 2% of all authors in the pre-Calman, 3% in the Calman, and 4% in the MMC periods. They were not the first author in any RCT in the pre-Calman period, rising to 7% in both the Calman and MMC periods. Our study shows that registrars involvement was at its highest in the pre-Calman era with gradual decline in their involvement in the subsequent training eras. SHO/Foundation doctors involvement remains very low, however showing increasing rate in the MMC era


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 500 - 500
1 Oct 2010
Walls R Mchugh G Moyna N O’Byrne J
Full Access

Introduction: After total knee arthroplasty (TKA) patients develop marked asymmetrical quadriceps femoris (QFM) weakness due to neurological activation deficits and muscle atrophy; this is associated with a slow (type I) to fast (type II) shift in myosin heavy chain (MHC) expression. Preoperative resistance training (prehabilitation) has been shown to improve strength and function after TKA however is considered costly and labour intensive. Neuromuscular electrical stimulation (NMES) offers the potential for unsupervised training, although its role in prehabilitation has not been investigated. Aims: Determine changes in myosin heavy chain (MHC) mRNA expression following preoperative NMES. Evaluate the ability of NMES prehabilitation to improve strength and functional recovery post-TKA. Methods: Randomised control efficacy study applying NMES to the affected QFM for 20 min, 5 days/week, for 8 weeks pre-TKA. Isometric QFM strength was determined dynametrically and muscle cross-sectional area (CSA) calculated from MRI axial images. Function was assessed with a walk test, stair-climb test, and chair-rise test. Real-time PCR analysed MHC mRNA expression. All evaluations were performed at baseline and preoperatively with strength, CSA and function also tested at 6 and 12 weeks post-TKA. Results: Patients scheduled for TKA were recruited and randomised into control (n=9) or NMES (n=5) groups. Only the NMES group increased strength (27.8%; p=0.05) and CSA (7.4%; p=0.013) preoperatively. MHC type II mRNA decreased by 42% (p=0.078) indicating a fast to slow fibre shift. Function also improved in the NMES group (stair climb [p=0.006]; chair rise [p=0.018]). While all patients deteriorated after surgery, only the NMES group had notable strength gain from 6 to 12 weeks (53%; p=0.011) with associated functional recovery (stair-climb, p=0.017; chair-rise, p=0.01; walking speed, p=0.014). There were differences seen between the groups at 3 months post-TKA: stair climb (61.6%, p=0.04) and chair rise (28.4%, p=0.013). There was greater muscle atrophy seen in the controls than the NMES group post-TKA when compared to baseline (12.1% [p=0.034] versus 3.7% [ns]). Conclusions: This study has shown that 8 weeks preoperative quadriceps strengthening using home-based NMES can safely and effectively attenuate the extent and duration of QFM weakness and atrophy after primary TKA. This translates into significantly faster functional recovery thereby expediting a return to normal activities


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 117 - 117
1 Sep 2012
Gupta A Cooke C Wilkinson M Grazette A
Full Access

Prospective Randomised Control trial of 300 patients over a period of 3 years, 1 year post op follow up. Local ethic approval was attained for the study. Inclusion criteria: Age > 60, Consented to Participate in the study, Unstable Inter trochanteric fracture a) Sub trochanteric b) Medial Comminution c) Reverse Obliquity D)Severe Osteoporosis. Patients selected were randomized to Intra medullary Nail vs Hips screw. Variety of markers have been assessed: Pre OP: - Mechanism of injury, Mobility status, Pre OP ASA, Pre Op haemoglobin, living Conditions. Intra OP:- I.I Time, Time taken, Surgeon experience, Intra OP complications. Post OP:- Haemoglobin, mobility, radiographic analysis-Fracture stability and Tip Apex Distance, Thrombo embolic Complications. Follow up: - 6 weeks, 3,6,12 month follow up. There is considerable debate in literature regarding superiority of Compression Hip screw over Intra medullary nail for fixation of stable per trochanteric fractures of the femur. Biomechanical studies have shown superiority of Intra medullary device over a Compression Hip screw. Tenser et all showed an advantage over combined bending and compression failure. Mohammad et al found unstable subtrochanteric fractures with a gamma nail were stiffer. Kerush-Brinker showed that gamma nail had significantly greater fatigue strength and fatigue life. In unstable fractures Baumgartner et al found less intra op complications and less fluoroscopic time for a compression hip screw compared to a short intra medullary nail. There have been significant reports of fracture at the Tip of a short intra medullary nail. We think this complication can be avoided by using a long intra medullary device. Both in Australia and abroad the choice of which device to use depends largely on the preference of the surgeon


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_25 | Pages 11 - 11
1 May 2013
Donaldson D Torkington M Anthony I Blyth M Jones B
Full Access

The longitudinal midline and medial-parapatellar incision are commonly used in Total Knee Arthroplasty (TKA). Medial-parapatellar incision n offers a smaller wound, avoids creation of thin skin flaps and easier exposure in obese patients. This incision creates a lateral skin flap which may be subject to poor blood supply and delayed wound healing. We undertook a Randomised Controlled Trial (n=20) comparing midline and medial-parapatellar incisions. Cutaneous blood-flow was measured using a Doppler Imager. Interstitial fluid measurements for lactate, pyruvate, lactate/pyruvate ratio and glucose were obtained from subcutaneous microdialysis catheters. Wound cosmesis was graded and skin sensation tested. Immediately post-op there was no significant difference in subcutaneous blood flow, but by day 3 patients with medial-parapatellar incisions showed greater bloodflow than midline incisions, particularly on the medial side (387 vs 278units p=0.148). At both day 1 and 3 post-op the lateral flap of the medial parapatellar incision showed decreased blood flow compared to the medial side, though these failed to reach significance. In contrast the midline incision showed no discernable difference in blood flow between the medial and lateral flaps. Concentrations of subcutaneous glucose increased from 4 hours post-op in the midline group, returning to baseline by 24hours. In contrast, the parapatellar group remained at base line throughout. Lactate concentrations increased over time in both groups peaking at 12hours post-op. No difference was noted between incision types with regard to wound cosmesis. We conclude that the use of a medial-parapatellar incision results in only minimal biochemical changes, which are unlikely to alter wound healing. Medial-parapatellar incision is therefore a safe alternative to a midline incision and can be utilised in appropriate complex cases to aid surgical exposure


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 240 - 240
1 Jul 2014
Bhattacharjee A Kuiper J Harrison P Roberts S Richardson J
Full Access

Summary. Randomised controlled study evaluating new bone formation in vivo in fracture non-unions by bone marrow derived stromal cells (BMSC). These cells do not show statistically significant new bone formation. Age of the patient during fracture, diabetes and doubling time had been observed to be correlated with fracture healing. Introduction. Regenerating new bone by cell therapy could provide therapeutic options in many conditions such as fracture non-unions and osteo-chondral defect regeneration in advance OA. In this randomised controlled study we evaluated the efficacy of new bone formation by bone marrow derived stromal cells (BMSC) in patients with non-union. Methods. An ethically approved and adequately powered single centre randomised control trial recruited 35 patients for treatment of non-unions with BMSC. Bone marrow was harvested and autologous BMSC were culture expanded in autologous serum at our local MHRA-licensed facility (Oscell, Oswestry, UK). Following selection by adherence and in vitro culture expansion using autologous serum, cells in serum and serum alone was randomised for insertion at one of the two fracture sides by StratOs® computer software. Patients and the operating surgeon were blinded to the side of cell insertion. Such method of randomisation created internal controls at the fracture sites- one side receiving the cell (‘test side’) and other, not (‘control’). Serial radiographs extending up to an average of twelve months were evaluated by four independent assessors blinded to side of cell insertion. Callus formation and bridging of fracture was compared for ‘test’ and ‘control’ side. Radiological and clinical outcome at final follow-up was also noted. Results. Thirty five patients were recruited (21 males, 14 females; mean age 51.2±13.2SD). The mean duration of non-union was 3±2SD years, with a mean 3.5 (range 1–12) surgical interventions prior to BMSC insertion. Five patients had diabetes. New callus formation and fracture bridging was slow, with no significant difference between the cell-insertion and control side although a substantial improvement in fracture bridging/formation of new callus was noted at 9–12 months. Fracture union was achieved in 21 patients at final follow-up with failure to progress to union in 14 patients. Age at accident, having diabetes and cell doubling time during culture predicted union (r2=0.63, p=0.017). There was no reported adverse effects from the trial. Conclusion. The study concluded that patient biology predicts the final outcome in cases with non-union of fracture. Slower doubling time during in vitro expansion can be significantly correlated with failure to unite in addition to diabetes and age of the patient. BMSC's are safe option for cell therapy in a setting of non-union although it failed to show statistically significant difference of new bone formation or fracture bridging for up to one year


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 18 - 18
1 Mar 2009
Poolman R Struijs P Krips R Sierevelt I Lutz K Zlowodzki M Bhandari M
Full Access

Background: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals. Methods: Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the four highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003–2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score. Results: We found that only the Journal of Bone and Joint Surgery–American Volume (JBJS-A) used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4%) were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence), these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p> 0.05). Among items closely corresponding to the Levels of Evidence Rating System criteria assessors achieved substantial agreement (ICC=0.80, 95%CI:0.60 to 0.90). Conclusions: Our findings suggest that readers should not assume that. 1) studies labelled as Level I have high reporting quality and. 2) Level I studies have better reporting quality than Level II studies. One should address methodological safeguards individually


Background: Neck pain is a common problem accounting for up to 22% of the workload of physiotherapists. Many different approaches are used and the evidence for these is unclear. Purpose: To evaluate the effectiveness of a brief physiotherapy intervention (1–3 sessions) for patients with neck pain in the primary care setting, taking preferences into account. Method: A Randomised controlled trial (n=268) compared a brief physiotherapy intervention based on cognitive-behavioural principles with ‘usual’ physiotherapy. Patients from physiotherapy waiting lists aged 18 – 87 years with neck pain of musculoskeletal origin of more than 2 weeks duration were invited to participate. Their preferences for type of treatment were elicited independently of randomisation. The brief intervention aimed to facilitate problem-solving, encourage self-management and early return to normal function. Physiotherapists undertook a one-day training programme in communication skills and cognitive-behavioural approaches. In the ‘Usual’ physiotherapy intervention treatment was provided at the discretion of the individual physiotherapist. The main outcome measures were the Neck Pain Questionnaire, a specific measure of functional disability due to neck pain, the SF-36 a generic health-related quality of life measure, the Tampa Scale for Kinesophobia, a measure of fear- and-avoidance of movement and the use of healthcare services. Data was collected at baseline, at 3 months and at 12 months. Results: Patients randomised to the ‘Usual’ physiotherapy group were significantly improved compared with the Brief Intervention group, 12 months after randomisation. However, the differences were small and patients randomised to the Brief Intervention who preferred that arm of the study also improved to a similar degree. In contrast, patients who wanted ‘Usual’ physiotherapy but got the brief Intervention did not improve. Conclusions: The Brief intervention may be effective for patients who prefer the option of a one-off treatment of advice. It is also cheaper and should therefore be offered as an option.ot


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1534 - 1541
1 Nov 2016
Sprowson† AP Jensen C Chambers S Parsons NR Aradhyula NM Carluke I Inman D Reed MR

Aims

A fracture of the hip is the most common serious orthopaedic injury, and surgical site infection (SSI) is one of the most significant complications, resulting in increased mortality, prolonged hospital stay and often the need for further surgery. Our aim was to determine whether high dose dual antibiotic impregnated bone cement decreases the rate of infection.

Patients and Methods

A quasi-randomised study of 848 patients with an intracapsular fracture of the hip was conducted in one large teaching hospital on two sites. All were treated with a hemiarthroplasty. A total of 448 patients received low dose single-antibiotic impregnated cement (control group) and 400 patients received high dose dual-antibiotic impregnated cement (intervention group). The primary outcome measure was deep SSI at one year after surgery.


The Bone & Joint Journal
Vol. 97-B, Issue 6 | Pages 786 - 792
1 Jun 2015
Hutt JRB Farhadnia P Massé V Lavigne M Vendittoli P

This randomised trial evaluated the outcome of a single design of unicompartmental arthroplasty of the knee (UKA) with either a cemented all-polyethylene or a metal-backed modular tibial component. A total of 63 knees in 45 patients (17 male, 28 female) were included, 27 in the all-polyethylene group and 36 in the metal-backed group. The mean age was 57.9 years (39.6 to 76.9). At a mean follow-up of 6.4 years (5 to 9.9), 11 all-polyethylene components (41%) were revised (at a mean of 5.8 years; 1.4 to 8.0) post-operatively and two metal-backed components were revised (at one and five years). One revision in both groups was for unexplained pain, one in the metal-backed group was for progression of osteoarthritis. The others in the all-polyethylene group were for aseptic loosening. The survivorship at seven years calculated by the Kaplan–Meier method for the all-polyethylene group was 56.5% (95% CI 31.9 to 75.2, number at risk 7) and for the metal-backed group was 93.8% (95% CI 77.3 to 98.4, number at risk 16) This difference was statistically significant (p <  0.001). At the most recent follow-up, significantly better mean Western Ontario and McMaster Universities Arthritis Index Scores were found in the all-polyethylene group (13.4 vs 23.0, p = 0.03) but there was no difference in the mean Knee injury and Osteoarthritis Outcome scores (68.8; 41.4 to 99.0 vs 62.6; 24.0 to 100.0), p = 0.36). There were no significant differences for range of movement (p = 0.36) or satisfaction (p = 0.23).

This randomised study demonstrates that all-polyethylene components in this design of fixed bearing UKA had unsatisfactory results with significantly higher rates of failure before ten years compared with the metal-back components.

Cite this article: Bone Joint J 2015;97-B:786–92.


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1464 - 1473
1 Nov 2013
Vendittoli P Rivière C Roy AG Barry J Lusignan D Lavigne M

A total of 219 hips in 192 patients aged between 18 and 65 years were randomised to 28-mm metal-on-metal uncemented total hip replacements (THRs, 107 hips) or hybrid hip resurfacing (HR, 112 hips). At a mean follow-up of eight years (6.6 to 9.3) there was no significant difference between the THR and HR groups regarding rate of revision (4.0% (4 of 99) vs 5.8% (6 of 104), p = 0.569) or re-operation rates without revision (5.1% (5 of 99) vs 2.9% (3 of 104), p = 0.428). In the THR group one recurrent dislocation, two late deep infections and one peri-prosthetic fracture required revision, whereas in the HR group five patients underwent revision for femoral head loosening and one for adverse reaction to metal debris. The mean University of California, Los Angeles activity scores were significantly higher in HR (7.5 (sd 1.7) vs 6.9 (sd 1.7), p = 0.035), but similar mean Western Ontario and McMaster Universities Osteoarthritis Index scores were obtained (5.8 (sd 9.5) in HR vs 5.1 (sd 8.9) in THR, p = 0.615) at the last follow-up. Osteolysis was found in 30 of 81 THR patients (37.4%), mostly in the proximal femur, compared with two of 83 HR patients (2.4%) (p < 0.001). At five years the mean metal ion levels were < 2.5 μg/l for cobalt and chromium in both groups; only titanium was significantly higher in the HR group (p = 0.001). Although revision rates and functional scores were similar in both groups at mid-term, long-term survival analysis is necessary to determine whether one procedure is more advantageous than the other.

Cite this article: Bone Joint J 2013;95-B:1464–73.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 8 | Pages 1101 - 1106
1 Aug 2012
Jindal N Sankhala SS Bachhal V

The purpose of this study was to determine whether patients with a burst fracture of the thoracolumbar spine treated by short segment pedicle screw fixation fared better clinically and radiologically if the affected segment was fused at the same time. A total of 50 patients were enrolled in a prospective study and assigned to one of two groups. After the exclusion of three patients, there were 23 patients in the fusion group and 24 in the non-fusion group. Follow-up was at a mean of 23.9 months (18 to 30). Functional outcome was evaluated using the Greenough Low Back Outcome Score. Neurological function was graded using the American Spinal Injury Association Impairment Scale. Radiological outcome was assessed on the basis of the angle of kyphosis.

Peri-operative blood transfusion requirements and duration of surgery were significantly higher in the fusion group (p = 0.029 and p < 0.001, respectively). There were no clinical or radiological differences in outcome between the groups (all outcomes p > 0.05). The results of this study suggest that adjunctive fusion is unnecessary when managing patients with a burst fracture of the thoracolumbar spine with short segment pedicle screw fixation.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 3 | Pages 391 - 397
1 Mar 2012
Parker MJ Bowers TR Pryor GA

In a randomised trial involving 598 patients with 600 trochanteric fractures of the hip, the fractures were treated with either a sliding hip screw (n = 300) or a Targon PF intramedullary nail (n = 300). The mean age of the patients was 82 years (26 to 104). All surviving patients were reviewed at one year with functional outcome assessed by a research nurse blinded to the treatment used. The intramedullary nail was found to have a slightly increased mean operative time (46 minutes (sd 12.3) versus 49 minutes (sd 12.7), p < 0.001) and an increased mean radiological screening time (0.3 minutes (sd 0.2) versus 0.5 minutes (sd 0.3), p <  0.001). Operative difficulties were more common with the intramedullary nail. There was no statistically significant difference between implants for wound healing complications (p = 1), or need for post-operative blood transfusion (p = 1), and medical complications were similarly distributed in both groups. There was a tendency to fewer revisions of fixation or conversion to an arthroplasty in the nail group, although the difference was not statistically significant (nine versus three cases, p = 0.14). The extent of shortening, loss of hip flexion, mortality and degree of residual pain were similar in both groups. The recovery of mobility was superior for those treated with the intramedullary nails (p = 0.01 at one year from injury).

In summary, both implants produced comparable results but there was a tendency to better return of mobility for those treated with the intramedullary nail.


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1425 - 1426
1 Nov 2016
Reed M Haddad FS


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 58 - 58
1 May 2017
Akimau P Dakin W Cawthron K Chadwick C Blundell C Davies M
Full Access

Background

Avulsion fractures of the base of the fifth metatarsal are some of the commonest foot injuries. The robust scientific evidence on the optimal non-operative treatment of these fractures is scant. We designed and conducted a prospective randomised non-inferiority controlled trial of symptomatic treatment versus cast immobilisation with the null hypothesis that cast immobilisation gave substantial benefit over the symptomatic treatment in terms of patient reported outcome measures(PROMs). The alternative hypothesis was that symptomatic treatment was not inferior.

Methods

The primary outcome was the validated Visual Analogue Scale Foot and Ankle (VAS FA) score ranging from 0 to 100. The non-inferiority boundary was set at −10 points. Power sizing determined a minimum of 12 patients per group. Anticipating a significant loss to follow up, 60 patients of 16 years of age or older were randomised to receive either below knee walking cast immobilisation (n = 24) or symptomatic double- elasticated bandage (n = 36) for 4 weeks. Secondary outcome measures were EuroQol-5D, and American Orthopaedic Foot and Ankle Society scores. Data was analysed at the baseline, 4 weeks, 3 months and 6 months post injury by a clinician blinded to a treatment arm.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 125 - 125
1 May 2016
Pauzenberger L Heuberer P Laky B Kriegleder B Anderl W
Full Access

Background

Tranexamic acid is an antifibrinolytic drug that has been shown to successfully reduce postoperative blood loss in total knee and hip arthroplasty. However, the efficacy of TXA following total shoulder arthroplasty has not been reported.

Purpose

The purpose of the present study was to evaluate the impact of intravenous TXA on postoperative blood loss and transfusion rates in total shoulder reconstruction.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 25 - 25
1 Feb 2018
Konstantinou K Rimmer Y Huckfield L Stynes S Burgess N Foster N
Full Access

Background

Recruitment to time and target in clinical trials is a key challenge requiring careful estimation of numbers of potential participants. The SCOPiC trial ((HTA 12/201/09) (ISRCTN75449581)) is investigating the clinical and cost-effectiveness of stratified care for patients with sciatica in primary care. Here, we describe the approaches followed to achieve recruitment of our required sample size (n=470), the challenges encountered and required adaptations.

Methods

We used recruitment data from the SCOPiC trial and its internal pilot, to show the differences between estimated and actual numbers of patients from consultation to participation in the trial. Patients were consented to the trial if they had a clinical diagnosis of sciatica (with at least 70% confidence) and met the trial eligibility criteria.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_20 | Pages 8 - 8
1 Dec 2017
Tian W Fan M Liu Y
Full Access

To introduce a new robot-assisted surgical system for spinal posterior fixation which called TiRobot, based on intraoperative three-dimensional images. TiRobot has three components: the planning and navigation system, optical tracking system and robotic arm system. By combining navigation and robot techniques, TiRobot can guide the screw trajectories for orthopedic surgeries.

In this randomised controlled study approved by the Ethics Committee, 40 patients were involved and all has been fully informed and sign the informed consent. 17 patients were treated by free-hand fluoroscopy-guided surgery, and 23 patients were treated by robot-assisted spinal surgery.

A total of 190 pedicle screws were implanted. The overall operation times were not different for both groups. None of the screws necessitated re-surgery for revised placement. In the robot-assisted group, assessment of pedicle screw accuracy showed that 102 of 102 screws (100%) were safely placed (<2 mm, category A+B). And mean deviation in entry point was 1.70 +/− 0.83mm, mean deviation in end point was 1.84 +/− 1.04mm. In the conventional freehand group, assessment of pedicle screw accuracy showed that 87 of 88 (98.9%) were safely placed (<2 mm, category A+B), 1 screw fall in category C, mean deviation in entry point was 3.73 +/− 2.28mm, mean deviation in end point was 4.11 +/− 2.31mm.

This randomised controlled study verified that robot-assisted pedicle screw placement with real-time navigation is a more accuracy and safer method, and also revealed great clinical potential of robot-assisted surgery in the future.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_23 | Pages 72 - 72
1 Dec 2016
Karlsen ØE Borgen P Bragnes BO Figved W Grøgaard B Rydinge J Sandberg L Snorrason F Wangen H Witso E Westberg M
Full Access

Aim

Prosthetic joint infection (PJI) is a much feared complication to arthroplasty with significant patient morbidity. Rifampin is increasingly used in staphylococcal PJIs treated with debridement and retention of the prosthesis. The evidence supporting rifampin combination therapy in PJIs is limited due to the lack of controlled studies. The aim of this study is to evaluate the effect of adding rifampin to conventional antimicrobial therapy in early staphylococcal PJIs treated with debridement and retention.

Method

In this multicentre randomized controlled trial, 99 patients with PJI after hip and knee arthroplasties were enrolled. All patients underwent a standardized surgical debridement. 65 patients had PJI caused by staphylococci and further included in the study. They were randomly assigned to receive rifampin or not in addition to standard antimicrobial therapy with cloxacillin, or vancomycin in case of methicillin resistance. They received parenteral antibiotics for two weeks, then oral antibiotics for 4 weeks. In case of methicillin resistance, vancomycin was administered i.v. for 6 weeks. The primary end point was no signs of infection after 2 wears follow-up.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_18 | Pages 3 - 3
1 Nov 2017
Duckworth A Clement N White T Court-Brown C McQueen M
Full Access

The aim of this prospective randomized controlled trial was to compare patient reported and functional outcomes, complications and costs for displaced olecranon fractures managed with either tension band wire (TBW) or plate fixation. We performed a registered prospective randomized, single blind, single centre trial in 67 patients aged between 16–74 years with an acute isolated displaced fracture of the olecranon. Patients were randomised to either TBW (n=34) or plate fixation (n=33). The primary outcome measure was the Disability Arm Shoulder and Hand (DASH) score at one-year.

The baseline demographic and fracture characteristics of the two groups were overall comparable. The one-year follow-up was 85percnt;. There was a significant improvement in elbow function over the 12 months following injury in both groups (p<0.001). At one-year following surgery the DASH for the TBW group was not statistically different to the plate fixation group (12.8 vs 8.5; p=0.315). There was no significant difference between groups in terms of range of movement, Broberg and Morrey Score, Mayo Elbow Score or the DASH at all assessment points over the one-year following injury (all p≥0.05). Complication rates were significantly higher in the TBW group (63percnt;vs38percnt;; p=0.042), predominantly due to a significantly higher rate of symptomatic metalwork removal (50percnt;vs22percnt;; p=0.021).

In active patients with an isolated displaced fracture of the olecranon, no difference was found in the patient reported outcome between TBW and plate fixation at one year following surgery. The complication rate is higher following TBW fixation due to a high rate of symptomatic metalwork removal.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_17 | Pages 18 - 18
1 Nov 2017
Singh B Bawale R Sinha S Gulihar A Tyler J
Full Access

Introduction

A recent meta-analysis published in the British Medical Journal suggested an increased risk of infection, but none of the studies were large enough to reach statistical significance. A prospective, randomised trial was designed at our institution to investigate the wound healing and complications related to surgery following fracture neck of femur in the elderly.

Objectives

The primary aim was to compare the wound problems and infection following two different methods of skin closure: Subcuticular monocryl suture to metal clips for closure of skin. The secondary aim was to look at the duration of surgery after both types of closure. We received ethical approval for this study. We screened and recruited all eligible patients admitted with acute hip fracture undergoing hemi-arthroplasty or dynamic hip screw.

We recruited 541 patients in the study over the period of 3.5 years at our institution.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 28 - 28
1 Nov 2016
Bhandari M Aleem I Aleem I Evaniew N Busse J Yaszemski M Agarwal A Einhorn T
Full Access

Electrical stimulators are commonly used to accelerate fracture healing, resolve nonunions or delayed unions, and to promote spinal fusion. The efficacy of electrical stimulator treatment, however, remains uncertain. We conducted a meta-analysis of randomised sham-controlled trials to establish the effectiveness of electrical stimulation for bone healing.

We searched MEDLINE, EMBASE, CINAHL and Cochrane Central to identify all randomised sham-controlled trials evaluating electrical stimulators in patients with acute fractures, non-union, delayed union, osteotomy healing or spinal fusion, published up to February 2015. Our outcomes were radiographic nonunion, patient-reported pain and self-reported function. Two reviewers independently assessed eligibility and risk of bias, performed data extraction, and rated overall confidence in the effect estimates according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Fifteen randomised trials met our inclusion criteria. Electrical stimulation reduced the relative risk of radiographic nonunion or persistent nonunion by 35% (95%CI 19% to 47%; 15 trials; 1247 patients; number needed to treat = 7; p < 0.01; moderate certainty). Electrical stimulation also showed a significant reduction in patient-reported pain (Mean Difference (MD) on the 100-millimeter visual analogue scale = −7.67; 95% CI −13.92 to −1.43; 4 trials; 195 patients; p = 0.02; moderate certainty). Limited functional outcome data showed no difference with electrical stimulation (MD −0.88; 95% CI −6.63 to 4.87; 2 trials; 316 patients; p = 0.76; low certainty).

Patients treated with electrical stimulation as an adjunct for bone healing have a reduced risk of radiographic nonunion or persistent nonunion and less pain; functional outcome data are limited and requires increased focus in future trials.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 124 - 124
1 Mar 2017
Zhou K Zhou Z Chen Z Wang D Pei F
Full Access

Purpose

Recently many authors have questioned the role of tourniquets in primary knee arthroplasty (TKA). Meanwhile, whether the use of an intra-articular wound drainage is an advance over the lack of a drain in TKA is controversial in the literature. This study aimed to investigate the efficacy and safety of drainage or not in TKA without a tourniquet.

Methods

Eighty participants who underwent primary unilateral TKA were prospectively enrolled and were randomized to one of two techniques during surgery without a tourniquet: drainage (Group A) or non-drainage (Group B). Blood loss was monitored perioperatively. The operating time, allogeneic blood transfusion rate, thigh pain, knee pain, limb swelling, clinical outcome as measured by the hospital for special surgery (HSS) score, the ability to straight-leg raise, visual analog scale (VAS) in pain, length of stay and knee active range of motion (ROM) were also recorded. The digital radiographs taken at 6 months postoperatively were assessed for cement mantle thickness and radiolucency using the Knee Society radiographic zones.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 56 - 56
1 Feb 2017
Kawata T Goto K So K Kuroda Y Okuzu Y Matsuda S
Full Access

Introduction

The long-term wear performance of highly cross-linked polyethylene (HXLPE) in cemented total hip arthroplasty (THA) has rarely been reported. Here we report a prospective randomized comparative analysis of radiographic wear after a minimum follow-up of 10 years in cemented THAs with either HXLPE or conventional polyethylene (CPE), and assess its clinical relevance.

Patients and Methods

From 1999 to 2001, we conducted 94 primary cemented THAs with a 22.225-mm head at our hospital as part of a prospective randomized trial. All surgeries were performed using a direct lateral approach with a trochanteric osteotomy (Dall's approach). The patients were divided into 4 groups. Twenty-six hips in group A were implanted with CPE sockets against zirconia heads and Charnley-type stems. HXLPE sockets (Aeonian, Kyocera Medical Corp) were implanted in all hips in the other 3 groups. Twenty-five hips in group B were implanted with zirconia heads and KC stems (Kyocera Medical Corp), 23 hips in group C with zirconia heads and distal cylindrical stems, and 20 hips in group D with stainless steel heads and C-stem (DePuy Inc). The sockets were highly cross-linked by gamma irradiation at a dose of 35 kGy, heat annealed at 110ºC, and sterilized with 25 kGy of gamma irradiation in nitrogen.

For radiographic evaluation, anteroposterior radiograms were taken for each patient annually, and every two years postoperatively for wear analyses. Two-dimensional head penetration was measured on each postoperative radiogram using a computer-aided technique.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 3 - 3
1 Dec 2016
Johnston D Beaupre L Alhoukail A
Full Access

Bearing surfaces in Total Hip Arthroplasty (THA) may affect implant longevity and hence patient outcomes. This randomised clinical trial (RCT) determined how ceramic-on-ceramic bearing (CERAMIC) THA affected joint-specific pain, function and stiffness, and prosthesis fixation/longevity over 10 postoperative years compared with ceramic-on-highly-crosslinked-polyethylene bearing (POLYETHYLENE) THA. This is a follow-up to previously reported five year outcomes.

Subjects aged less than 61 years were randomised to CERAMIC [n=48] or POLYETHYLENE [n=44] THA. Subjects were assessed using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and the RAND 12-Item Health Survey (RAND-12) preoperatively, and at one, five and 10 years postoperatively. Plain radiographs were evaluated at 10 years for fixation and medical records were reviewed for revisions.

Of 92 subjects, six (7%) died within 10 years; 68 (79%) survivors provided radiographic and/or clinical follow-up at 10 years postoperatively. Improvements seen at five years in both the WOMAC and RAND-12 were retained at 10 years with no group differences (p>0.48). There were no failures/loss of fixation related to bearing surfaces/wear in either group. Over 10 years, three subjects in the POLYETHYLENE group had revisions that were related to recurrent dislocation; two revisions were performed within two years of surgery and one further subject underwent revision at 7 years postoperatively.

This is one of the first RCTs to examine 10 year outcomes between ceramic-on-ceramic and ceramic-on-highly-crosslinked-polyethylene bearing THA. Both bearing surfaces performed well out to 10 years in subjects who were less than 61 years at time of surgery.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_13 | Pages 34 - 34
1 Sep 2014
Schepers A v d Jagt D Breckon A
Full Access

Purpose Of Study

The study was started in 2004 to determine the best bearing surface in the long term, and to measure the metal ion levels generated by each of the bearing surfaces. We present the latest updated results.

Material and methods

A prospective randomised study was started in 2004 to compare the wear characteristics of Ceramic on X linked Polyethylene (C.O.P.), Ceramic on Ceramic (C.O.C), Ceramic on Metal (C.O.M.) and Metal on Metal (M.O.M) bearings. The level of Cobalt and Chrome ions in red blood cells have been documented at serial intervals, using the ICP – MS method. Aside from the bearing surfaces the rest of the implant is standard, using a Pinnacle Cup, Corail Stem and 28mm heads.

256 Cases were enrolled on the study. To date 71 cases have been lost due to death (26), revision (9) and lost to follow up (36), leaving us with 185 for follow-up. An even spread of cases in each bearing surface are still available for follow up, viz. 46 C.O.P, 48 C.O.C., 44 C.O.M. and 47 M.O.M. Average follow up is currently 4.8 years, ranging up to 9 years.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 93 - 93
1 Nov 2016
Weeks C Somerville L Phillips J Ganapathy S Howard J
Full Access

The use of spinal anesthesia with adjuvant intra-thecal opioids has been commonly used in total knee arthroplasty without documented clinical benefit. It has been associated with a potential increase in side effects, including nausea, vomiting, pruritus, urinary retention and oxygen usage. This double-blinded RCT investigated whether the addition of epimorph to spinal anesthesia in patients undergoing total knee arthroplasty resulted in superior pain control and decreased narcotic consumption without also causing an increase in postoperative complication rates.

We performed a prospective double-blind trial in patients undergoing primary total knee arthroplasty (TKA). Patients were randomised to receive either spinal anesthesia alone or spinal anesthesia with epimorph (150 ug). All patients received infiltration of a local anesthetic cocktail intraoperatively. Both the study patients and staff measuring outcomes were blinded to the experimental treatment received during data collection. Postoperatively, visual analogue scale (VAS) for pain was recorded at 6, 12, 18, 24, 36 and 48hrs and a final value at 1 week. Narcotic use, Foley insertion, oxygen requirements, nausea, vomiting and pruritus were recorded during the course of hospitalisation.

Forty-one patients were randomised into each of the spinal with epimorph and spinal alone treatment arms. The groups showed no significant differences in BMI, age, and gender distribution. In the first 12 hours postoperatively there was no difference in VAS for pain between the two groups, however there were significantly lower pain scores in the spinal alone patients at 18 hours (p=0.002), 24 hours (p=0.04) and 48 hours (p = 0.03) compared to the spinal with epimorph group. Narcotic usage was greater in the spinal group during the first 6 hours postoperatively, but beyond this time point narcotic usage was similar between the two groups. Additionally, there was a statistically significant increase in rate of complications with spinal epimorph including nausea (p=0.037) and pruritus (p=0.024). The incidence of urinary retention was greater in the spinal epimorph group, however this did not reach statistical significance.

This study demonstrates no clinical benefit with the addition of intra-thecal opioids to spinal anesthetic in primary TKA. In addition to a failing to reduce VAS pain scores and overall narcotic consumption, increased complication rates were seen. For these reasons, this study does not support the use of epimorph in addition to spinal anesthesia for pain control in TKA.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_5 | Pages 11 - 11
1 Feb 2016
Merloz P Ruatti S Dubois C Chipon E Kerschbaumer G Milaire M Moreau-Gaudry A Tonetti J Dao Lena S
Full Access

Introduction

We report a single-centre, prospective, randomised study for pedicle screw insertion, by using a Computer Assisted Surgery (CAS) technique with three dimension (3D) intra-operative images intensifier versus conventional surgical procedure.

Methods

143 patients (68 women and 75 men) were included in this study. 72 patients underwent conventional surgery (C = conventional). 71 patients were operated on with the help of a 3D intra-operative imaging system (N = navigated). We performed 34 percutaneous surgeries in group N and 37 in group C; 25 open surgeries in group N and 35 in group C. 382 screws were implanted in group C and 174 in group N. We measured the pedicle screw running-time, and surgeon's radiation exposure. All pedicle runs were assessed according to Heary's classification by two independent radiologists on a post-operative CT.


Femoroacetabular impingement (FAI) is a condition of the hip where there is a mismatch of the femoral head and hip acetabulum. This mismatch creates abnormal contact between the bones and causes hip pain which can lead to damage, and eventually osteoarthritis of the hip. The diagnosis and treatment of FAI has become one of the most popular clinical scenarios in orthopaedic surgery, with hip arthroscopy procedures increasing exponentially over the past five years. Surgical intervention usually involves correcting the existing deformities by reshaping the ball and socket (“osteoplasty” or “rim trimming”) so that they fit together more easily while repairing any other existing soft tissue damage in the hip joint (e.g. labral repair). Although correction of the misshaped bony anatomy and associated intra-articular soft tissue damage of the hip is thought to appease impingement and improve pain and function, the current evidence is based on small, observational, and low quality studies. A lack of definitive evidence regarding the efficacy of osteochondroplasty in treating FAI fueled the design and execution of the FIRST randomized controlled trial (RCT). FIRST evaluated the impact of surgical correction of the hip impingement morphology with arthroscopic osteochondroplasty versus arthroscopic lavage on pain, function, and quality of life in adults aged 18–50 years diagnosed with non-arthritic FAI at one year.

FIRST was a large definitive RCT (NCT01623843) enrolling patients with FAI requiring surgical intervention across 11 international clinical sites. Participants were randomized to either arthroscopic osteochondroplasty (shaving of bone) or lavage (washing the joint of painful inflammation debris). The primary outcome was patient-reported pain within one year of the initial surgery measured using the Visual Analogue Scale (VAS). Secondary outcomes included function, health utility, and health-related quality of life using several general and hip-centric health questionnaires. An independent, blinded adjudication committee evaluated the quality of surgery, re-operations, and other patient complications. Patients and data analysts were blinded to the treatment groups.

Two-hundred and twenty participants were enrolled into the FIRST trial over a six-year period (pilot phase: N=50, from 2012–2013 and definitive phase: N=170, from 2015–2018) at 11 clinical sites in Canada, Finland, and Denmark. The FIRST results will be released at the ISAKOS annual meeting as follows. The absolute difference in rate of pain reduction between groups was XX (95% CI: YY-YY, p=X). The mean differences of the Short-Form 12 (SF-12, MCS and PCS), Hip Outcome Score (HOS), International Hip Outcome Tool (iHOT-12), and EuroQol 5-Dimensions (EQ-5D) between groups are XX (95% CI: YY-YY, p=X)…, respectively. Reoperations occurred in XX of 220 (X%) patients over the one-year follow up period (OR:XX, 95% CI: YY-YY, p=X) and the patients treated with arthroscopic osteochondroplasty conferred the following risk of reoperation within one-year compared to arthroscopic lavage (RR:XX, 95% CI: YY-YY, p=X).

This RCT represents major international efforts to definitively identify the optimal treatment strategy for FAI. The results of this trial will change practice, being used to prevent chronic hip pain and loss of function caused by hip osteoarthritis.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 90 - 90
1 Mar 2017
Wellman S Queen R
Full Access

Introduction

Mid-flexion stability after total knee arthroplasty (TKA) is dependent, in large part, on implant design. Design variables include retention or sacrifice of the posterior cruciate ligament, conformity of the polyethylene tibial surface, and radius of curvature of the femoral component. In this study, we attempted to isolate the impact of femoral component design by comparing a single-radius design (SR) to a J-Curve design (JC). We selected cruciate-retaining implants to eliminate the effect of a cam-and-post mechanism. Mid-flexion performance these two designs were compared using the Lower-Quarter Y-Balance Test (YBT-LQ), as well as patient reported outcomes and measures of physical performance. The YBT-LQ is a simple functional test of unilateral lower extremity strength and balance. Reach of the contralateral limb is measured in three different directions (Figures 1–3). Our hypothesis was that the SR design would provide superior mid-flexion stability, and therefore, a greater reach distance in the YBT-LQ when compared to the JC group.

Methods

Patients undergoing primary, unilateral TKA were prospectively enrolled and block randomized to receive either the SR (n=30) or JC (n=30) implant. All surgeries were performed by one surgeon using a gap-balancing technique with a cruciate-retaining implant design. Patients completed outcome measures (KOOS, KSS, UCLA Activity), performed the YBT-LQ, and completed physical performance measures (walking speed, timed up-and-go, sit-to-stand) before surgery and 1 year postoperatively. A series of 2×2 repeated measures ANOVAS (Implant group x Time) were completed.


Purpose

Previous studies have demonstrated pronounced reduction of sleep quality following major surgery, which may affect postoperative pain and early recovery. This prospective, randomized, controlled trial was designed to evaluate the effect of zolpidem on sleep quality in fast-track total knee arthroplasty (TKA).

Methods

180 patients who underwent primary TKA were enrolled in this study and randomized 1:1 to receive either zolpidem (Group A) or placebo (Group B) for 6 days. VAS pain scores (rest, ambulation, flexion, and night), range of motion (ROM), opioid analgesics use, postoperative nausea and vomiting (PONV) and other complication, sleep efficacy and patients VAS satisfaction were recorded postoperatively and at 1, 3, 5 after surgery. Sleep quality was measured using the polysomnography (PSG) and Epworth Sleepiness Scale.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 42 - 42
1 Dec 2017
Scarborough M Li HK Rombach I Zambellas R Walker S Kumin M Lipsky BA Hughes H Bose D Warren S Geue C McMeekin N Woodhouse A Atkins B McNally M Berendt T Angus B Byren I Thwaites G Bejon P
Full Access

Aim

Current standard of care in the management of bone and joint infection commonly includes a 4–6 week course of intravenous (IV) antibiotics but there is little evidence to suggest that oral antibiotic therapy results in worse outcomes. The primary objective was to determine whether oral antibiotics are non-inferior to IV antibiotics in this setting.

Method

This was a parallel group, randomised (1:1), open label, non-inferiority trial across twenty-six NHS hospitals in the United Kingdom. Eligible patients were adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least six weeks of antibiotics and who had received ≤7 days of IV therapy from the date of definitive surgery (or the start of planned curative treatment in patients managed non-operatively). Participants were randomised to receive either oral or IV antibiotics for the first 6 weeks of therapy. Follow-on oral therapy was permitted in either arm. The primary outcome was the proportion of participants experiencing definitive treatment failure within one year of randomisation. The non-inferiority margin was set at 7.5%.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 109 - 109
1 Jan 2017
van Hamersveld K Valstar E Toksvig-Larsen S
Full Access

Whether it is best to retain the posterior cruciate ligament in the degenerated knee, i.e. using a cruciate-retaining (CR) total knee prosthesis (TKP), or to use a more constraint posterior-stabilized (PS) TKP is of debate. There are limited studies comparing the effect of both methods on implant fixation and clinical outcome, leaving it up to the surgeon to base this decision on anything but conclusive evidence. We assessed the effect of two different philosophies in knee arthroplasty on clinical outcome and tibial component migration measured with radiostereometric analysis (RSA), by directly comparing the CR and PS version of an otherwise similarly designed cemented TKP.

Sixty patients were randomized and received a Triathlon TKP (Stryker, NJ, USA) of either CR (n=30) or PS (n=30) design. RSA measurements (primary outcome) and clinical scores including the Knee Society Score and Knee injury and Osteoarthritis Outcome Score were evaluated at baseline, at three months postoperatively and at one, two, five and seven years. A linear mixed-effects model was used to analyse the repeated measurements.

Both groups showed a similar implant migration pattern, with a maximum total point motion at seven years follow-up of around 0.8 mm of migration (mean difference between groups 95% CI −0.11 to 0.15mm, p=0.842). Two components (one of each group) were considered to have an increased risk of aseptic loosening. Both groups improved equally after surgery on the KSS and KOOS scores and no differences were seen during the seven years of follow-up.

No differences in implant migration nor clinical results were seen seven years after cruciate-retaining compared to posterior-stabilized total knee prostheses.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_12 | Pages 7 - 7
1 Jun 2016
Stone OD Ray R Thomson C Gibson J
Full Access

There is a paucity of published literature regarding the long-term outcomes of the modern generations of total joint arthroplasty (TJA) of the first metatarsophalangeal joint. Between 1999 and 2001, we recruited 63 patients into a randomised controlled trial of arthrodesis vs TJA. The 2 year results were published in 2005.

At a mean follow-up 15.2 years (range 13.2–17.2), all patients from the original trial were contacted. Data were collected in the form of visual analogue score for pain (VAS), visual-Analogue-Scale Foot and Ankle (VAS FA) as well as information on any revision procedures.

Data were available from all surviving patients (66 toes 53 patients). There was no difference in pain scores between the arthrodesis group and arthroplasty group 7.4 ± 15.7 vs 15.7 ± 19.7 (p=0.06). There was also no difference in the VAS FA scores as a whole 88.9 ± 12.9 vs 86.1 ± 17.1 (p = 0.47), or when divided into its 3 components (pain, function and other complaints). There was however a significant difference with regards to patient satisfaction with the arthrodesis group outperforming the TJA group: 95.5 ± 10.4 vs 83.6 ± 20.9 (p<0.01). There was a significantly higher rate of revision surgery in the TJA group when compared to the arthrodesis group (p= 0.009).

At 15 years the patients that underwent arthrodesis were more satisfied and had a greater survivorship compared to TJA, however there was no difference in outcome with regards to pain or function between the two groups. Based on the results of this study arthrodesis remains the ‘gold standard’ due to excellent pain relief, high function and low risk of revision surgery.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_23 | Pages 23 - 23
1 Dec 2016
Uckay I Von Dach E Lipsky BA
Full Access

Aim

The optimal surgical approach for patients hospitalized for moderate to severe septic bursitis is not known, and there have been no randomized trials of a one-stage compared with a two-stage (i.e., bursectomy, followed by closure in a second procedure) approach. Thus, we performed a prospective, non-blinded, randomized study of adult patients hospitalized for an open bursectomy.

Method

Patients were randomized 1:1 to a one-stage vs. a two-stage surgical approach. All patients received postsurgical oral antibiotic therapy for 7 days. These are the final results of the prospective study registered at ClinicalTrials (NCT01406652).


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 14 - 14
1 Dec 2016
Sheps D Chepeha J Magee D Beaupre L
Full Access

Athletes involved in repetitive overhead shoulder rotation demonstrate increased external rotation and decreased internal rotation range of motion. Deficits in internal rotation have been linked to the development of shoulder pathology. The purpose of this study is to determine if a posterior shoulder stretch program is effective in increasing dominant arm internal rotation and horizontal adduction range of motion in overhead athletes identified as having reduced mobility and posterior shoulder tightness.

Thirty-seven overhead athletes in volleyball, swimming and tennis, with internal rotation range of motion deficits greater than or equal to 15°, were randomised into intervention or control groups. The intervention group performed the “sleeper stretch” daily for eight weeks while the control group performed usual activities. Independent t-tests determined whether internal rotation and horizontal adduction range of motion differences between groups were significant and two-way repeated measures analysis of variance tests measured the rate of shoulder range of motion change. Reported shoulder pain and function were also obtained at each evaluation.

Significant differences were found between the intervention and control groups' internal rotation and horizontal adduction range of motion at eight weeks (p<0.001 and p=0.003 respectively) compared to baseline (zero weeks) (p=0.19 and p=0.82 respectively). Significant changes in internal rotation were detected in the intervention group at four weeks (p<0.001) with further adaptations noted at eight weeks. Horizontal adduction improved at a slower rate demonstrating significant changes at eight weeks (p=0.003). Reported shoulder pain and functional ability (p=0.002) were different between the study groups at eight weeks.

Overhead, collegiate-level athletes with an internal rotation deficit greater than or equal to 15° are able to significantly increase internal rotation and horizontal adduction range of motion by performing a posterior shoulder stretch exercise for eight weeks.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 42 - 42
1 May 2016
Singh S Yadav C Kumar A Kumar N
Full Access

Introduction

To reduce several disadvantages many surgeons are not using tourniquet in TKA. Here we compared functional outcome along with pain and blood loss in sixty patients.

Material and Method

60 patients who underwent TKA wererandomized into a tourniquet group (n2 = 30) and a non-tourniquet group (n1 = 30). All operations were performed by the samesurgeon and follow-up was for 6 month. Primary outcomes werefunctional and clinical outcomes, as evaluated by KSS and postoperative pain. Secondary outcomes were blood loss, surgical time and visibility, extensor lag and Knee ROM, DVT and radiolucency.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 95 - 95
1 Nov 2016
Howard J Vijayashankar R Sogbein O Ganapathy S Johnston D Bryant D Lanting B Vasarhelyi E MacDonald S
Full Access

Pain immediately following total knee arthroplasty (TKA) is often severe and can inhibit patients' rehabilitation. Recently, adductor canal blocks have been shown to provide adequate analgesia and spare quadriceps muscle strength in the early postoperative period. We devised a single injection motor sparing knee block (MSB) by targeting the adductor canal and lateral femoral cutaneous nerve with a posterior knee infiltration under ultrasound. Our primary objective was to evaluate the analgesia duration of the MSB in comparison to a standard periarticular infiltration (PAI) analgesia using patients' first rescue analgesia as the end point. Secondary outcomes measured were quadriceps muscle strength and length of stay.

We randomised 82 patients scheduled for elective TKA to receive either the preoperative MSB (0.5% ropivacaine, 2.5ug/ml epinephrine, 10mg morphine, and 30mg ketorolac) or intraoperative periarticular infiltration (0.3% ropivacaine, 2.5ug/ml epinephrine, 10mg morphine, and 30mg ketorolac). Duration of analgesia, postoperative quadriceps power, and length of stay were evaluated postoperatively.

Analgesic duration was found to be significantly different between groups. The MSB had a mean duration of 18.06 ± 1.68 hours while the PAI group had a mean duration of 9.25 ± 1.68 hours for a mean difference of 8.8 hours (95% CI 3.98 to 13.62), p<0.01. There were no significant differences between groups in quadriceps muscle strength power at 20 minutes (p=0.91) or 6 hours (p=0.66) after block administration. Length of stay was also not significantly different between the groups (p=0.29).

Motor sparing blocks provide longer analgesia than patients receiving periarticular infiltration while not significantly reducing quadriceps muscle strength or increasing length of hospital stay.


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1526 - 1533
1 Nov 2016
van Tilburg CWJ Stronks DL Groeneweg JG Huygen FJPM

Aims

The aim of this study was to compare the effect of a percutaneous radiofrequency heat lesion at the medial branch of the primary dorsal ramus with a sham procedure, for the treatment of lumbar facet joint pain.

Patients and Methods

A randomised sham-controlled double blind multicentre trial was carried out at the multidisciplinary pain centres of two hospitals. A total of 60 patients aged > 18 years with a history and physical examination suggestive of facet joint pain and a decrease of ≥ 2 on a numerical rating scale (NRS 0 to 10) after a diagnostic facet joint test block were included. In the treatment group, a percutaneous radiofrequency heat lesion (80oC during 60 seconds per level) was applied to the medial branch of the primary dorsal ramus. In the sham group, the same procedure was undertaken without for the radiofrequency lesion. Both groups also received a graded activity physiotherapy programme. The primary outcome measure was decrease in pain. A secondary outcome measure was the Global Perceived Effect scale (GPE).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 26 - 26
1 Jan 2013
Tilbrook H Cox H Hewitt C Chuang L Jayakody S Kanǵombe A Aplin J Semlyen A Trewhela A Watt I Torgerson D
Full Access

Purposes of the study and background

Smaller studies indicate that yoga may be an effective treatment for chronic low back pain. We conducted a randomised trial to evaluate if yoga compared to usual care improves back function in patients with chronic or recurrent low back pain.

Summary of the methods used and the results

Outcomes were assessed by postal questionnaires. The setting was 13 non-National Health Service premises. We recruited 313 adults with chronic or recurrent low back pain from primary care. 157 were randomised to usual care. 156 were randomised to a 12-class, gradually-progressing programme of yoga delivered by 12 teachers over three months. All received The Back Book.

Primary outcome was back function (Roland Morris Disability Score) at three months. Secondary outcomes: back function at six and 12 months, back pain, pain self-efficacy and general health.

Back function improved more in the yoga group: mean difference in changes from baseline at three (−2.17, 95% CI −3.31 to −1.03, p<0.001), six (−1.48, 95% CI −2.62 to −0.33, p=0.011) and 12 months (−1.57, −2.71 to −0.42, p=0.007). Improvement in pain self-efficacy at three and six months in the yoga group. No differences in general health and pain reduction.

Two adverse events were reported by controls and 12 by the yoga group – 8 out of 12 reported pain which may have been due to yoga. 63 (40%) were not fully compliant with treatment and 23 (15%) did not attend any yoga classes.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 81 - 81
1 Nov 2016
Tucker A Bicknell R Hiscox C
Full Access

Estimated to affect 2–5% of the population, adhesive capsulitis is a common cause of shoulder pain and dysfunction. The objective of this study is to determine if arthrographic injection of the shoulder joint with steroid, local anesthetic and contrast is an effective treatment modality for adhesive capsulitis and whether it is superior to arthrographic injection with local anesthetic and contrast alone.

This is a double-blinded RCT of patients with a diagnosis of adhesive capsulitis who were randomly assigned to receive an image guided arthrographic glenohumeral injection with either triamcinalone (steroid), lidocaine (local anesthetic) and contrast or lidocaine and contrast alone. Outcome measures included active and passive shoulder range of motion (ROM) and functional outcomes assessed using the Shoulder Pain and Disability Index (SPADI), the Constant Score and a Visual Analog Scale for pain. Post-operative evaluation occurred at 3 weeks, 6 weeks and 12 weeks. Descriptive statistics were utilised to summarise patient demographics and other study parameters. One-way ANOVAs compared the VAS, Constant and SPADI scores across the different time points for both study groups. The post hoc Bonferroni correction was used to adjust for multiple comparisons.

There were 37 shoulders injected with follow-up visits at 12 weeks. Twenty shoulders were randomised to receive local plus steroid and 17 shoulders received local anesthetic only. There were 21 females and 14 males with an average age of 54 years (range, 42–70). VAS scores for both patient groups were significantly improved (p<0.05) at all follow-up times. Goniometric testing demonstrated significant improvements in forward flexion and internal rotation at 90 degrees in the local group and only abduction in the local plus steroid group. There were no significant changes in the Constant scores for the local group (p=0.08), however, the Constant scores showed significant improvement for the local plus steroid group (p=0.003) at all follow-up time points. The local group showed significant improvement in their SPADI pain scores at the 12 week follow-up only (p=0.01). There were no significant differences in their SPADI disability scores (p=0.09). The local plus steroid group had significant improvement in SPADI pain and disability scores at all follow-up time points (p=0.001).

The optimal treatment for adhesive capsulitis remains unclear. Our study demonstrated that patients receiving an arthrographic injection of either steroid and local anesthetic or local anesthetic alone had significantly improved post-injection pain scores. However, only the steroid and local anesthetic group demonstrated improved SPADI disability and Constant scores. Thus, we believe that either treatment may be a good option for patients with adhesive capsulitis and can reliably relieve pain, but we would recommend the steroid with local anesthetic over the local anesthetic alone as it may provide improved function.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 111 - 111
1 Mar 2012
Pydisetty R Newman J
Full Access

Between 1989 and 1992 102 knees adjudged suitable for Unicompartmental replacement (UKR) were randomised to receive either a St Georg Sled UKR or a Kinematic modular total knee replacement (TKR). The early results demonstrated that the UKR group had less complications, and more rapid rehabilitation. At 5 years there were equal failures but the UKR group had more excellent results and a greater range of movement.

Despite this doubt persisted about whether these advantages would be maintained these cases have been followed regularly by a research nurse at 8, 10, 12 years. We now report the final outcome at 15 years. 43 patients (45 knees) have died with all their knees intact. Throughout the review period the Bristol Knee Scores (BKS) of the UKR group have been better and at 15 years 77% and 53% of the surviving UKRs and TKRs achieve an excellent score. 6 TKRs and 4 UKRs have failed during the 15 years of the review.

Conclusion

The better early results with UKR are maintained at 15 years with no greater failure rate. The median BKS scores of the UKR group was 91.1 at five years and 92 at 15 years suggesting little functional deterioration in either the prosthesis or remainder of the joint. These results would seem to justify the increased use of UKR.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_III | Pages 146 - 146
1 Feb 2012
Maor D Haebich S Nivbrant B Wood D Khan R
Full Access

Aim

The aim of this study was to compare a single-incision minimally invasive (MI) posterior approach with a standard posterior approach in a double-blind prospective randomised controlled trial.

Method

A pilot study was carried out to assess the efficacy of the MI approach. Primary total hip replacements meeting the inclusion criteria were randomised to either the MI approach or the standard posterior approach. Patients were blinded to allocation. Patients were scored by a blinded physiotherapist pre-operatively, at Day 2, 2 weeks and 6 weeks.

The primary outcome measure was function, assessed using the Oxford hip score, SF-12 questionnaire, Iowa score, 6-minute walk test and the number of walking aids required after 2 and 6 weeks post-operatively. Secondary outcomes were complication rates, patient satisfaction, soft tissue trauma and radiographic analysis.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 248 - 248
1 May 2009
Roy L Amiot LP Poulin F
Full Access

To prospectively evaluate the accuracy as well as patient outcome of computer-assisted total knee replacement in a multi-centric randomised study.

Two hundred and ninety-five patients in six European centers were randomised between two groups: One hundred and forty-seven in the conventional surgery group and one hundred and forty-eight in the computer assisted surgery. Radiological as well as clinical data (SF-36 and KSS scores) were collected preoperatively as well as six weeks and six months postoperatively. A multilevel mixed-effects linear regression for nested variable with random-effects was used to estimate the effect of the independent variable (type of surgery: conventional surgery vs computer assisted surgery) on each of the dependent variables at six weeks and six months post-operatively.

Mechanical axis was statistically better in the navigation group at six weeks (p=0,01) and six months (p=0,04). Similar results are found for the femoral component at six months (p=0,001). At six months, there were statistically greater improvements in the following SF-36 scales for the computer assisted group: bodily pain (p=0,03), role emotional (p=0,03), mental health (p< 0,001), physical health dimension (p=0,01), mental health dimension (p=0,005) and global SF36 score (p=0,002). While a difference in operating time was noted (p< 10-5), the blood losses where similar for both groups (p=0.8).

Computer assisted surgery improves the accuracy in total knee arthroplasty, especially for the mechanical axis and the femoral component orientation. These improvements result in better quality of life for the patient at six months postoperatively. Level of Evidence: I – High-quality randomised controlled trial with statistically significant difference.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 5 - 5
1 Jul 2014
Porter A Snyder B Franklin P Ayers D
Full Access

Summary Statement

A prospective randomised evaluation of primary TKA utilizing patient specific instruments demonstrated great accuracy of bone resection, improved sagittal alignment and the potential to improve functional outcomes and reduce operating room costs when compared to standard TKA instrumentation.

Introduction

Patient specific instruments (PSI), an alternative to standard total knee arthroplasty (TKA) technology, have been proposed to improve the accuracy of TKA implant placement and post-operative limb alignment. Previous studies have shown mixed results regarding the effectiveness of PSI. The purposes of this study were (1) to evaluate the accuracy of the pre-operative predicted PSI plan compared to intra-operative TKA resection measurements, (2) to compare patient-reported outcome measures of PSI and standard TKA patients, and (3) to compare the incremental cost savings with PSI.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 123 - 123
1 Jan 2016
Watanabe N Aiba H Sagara G Yamagami T Nishimori Y Waseda Y Oguri Y Onogi H Sakurai H Otsuka T
Full Access

Purpose

According to Bipolar Hemiarthroplasty of the Hip (BHA), several reports indicated earlier acquisition of walking ability in direct anterior approach (DAA) than posterior approach (PA), but there is still few randomized studies comparing accuracy of stem insertion in DAA and PA. Therefore, we performed a prospective study, focusing positioning of implant.

Patient and Methods

We chose 29 patients for this study, diagnosed as femoral neck fracture (Garden grade III or IV) from April 2012 to April 2013, excluding obesity patients (body mass index upper than 30kg/m2), muscular patients, osteoporotic patients (Sigh grade I or II), and tumor bearing patients. Patients were enrolled in a prospective, non-blinded study and were randomly assigned by envelope method to receive either DAA or PA. Taperloc BHA system (Zimmer) was adapted for all cases. Patient condition, operation condition and radiographic findings were investigated. On CT imaging, Canal fill was calculated Stem fill was studied at lower point of lesser trochanter that was considered to be load center. Static analysis was carried out using SPSS ver21 (IBMc). Continuous variables between the two groups were compared using a no matched bilateral Student's t-test. For nominal variables we used χ2test. P value <0.05 was considered to be significant. (Table1)


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 43 - 43
1 Dec 2017
Alvand A Li HK Rombach I Zambellas R Kendrick B Taylor A Atkins B Bejon P McNally M Scarborough M
Full Access

Aim

To assess the influence of route of antibiotic administration on patient-reported outcome measures (PROMS) of individuals treated for hip and knee infections in the OVIVA multi-centre randomised controlled trial.

Method

This study was designed to determine whether oral antibiotic therapy is non-inferior to intravenous (IV) therapy when given for the first six weeks of treatment for bone and joint infections. Of the 1054 participants recruited from 26 centres, 462 were treated for periprosthetic or native joint infections of the hip or knee. There were 243 participants in the IV antibiotic cohort and 219 in the oral cohort. Functional outcome was determined at baseline through to one year using the Oxford Hip/Knee Score (OHS/OKS) as joint-specific measures (0 the worse and 48 the best). An adjusted quantile regression model was used to compare functional outcome scores.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 21 - 21
1 Apr 2013
Wardlaw D Vadhva M Sabboubeh A
Full Access

Purpose of the Study

Assessment of long term results of Chemonucleolysis vs. surgery for soft disc herniation

Material and Methods

From 1982 to 1985, 100 patients with symptomatic disc herniation were randomly allocated to receive either Chemonucleolysis(48) or surgery(52) after a three months trial of conservative treatment. Ten of the chemonucleolysis had surgery. At 10–13 year follow up, Sixty one of the original 100 patients responded, (32 chemonucleolysis; 29 surgery). At 25–27 year Forty four patients responded (24 chemonucleolysis; 20 surgery). Clinical outcome at one year was according to a self-assessment questionnaire: Completely, better improved, the same, or worse, and at the later follow up periods, according to the Macnab criteria. The results of two groups of patients were compared using Chi square and T test for independent samples.

The disc height of the affected disc was measured from the lateral lumbar spine radiograph taken pre-operatively, and at the later two time points, and compared to a normal adjacent disc expressed as a percentage.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_15 | Pages 67 - 67
1 Dec 2015
Milandt N Nymark T Kolmos H Emmeluth C Overgaard S
Full Access

We conducted a randomized controlled trial (RCT) to investigate if iodine impregnated incision drapes (IIID) increases bacterial recolonization rates compared to no drape use under conditions of simulated total knee arthroplasty (TKA) surgery.

Background: To prevent surgical site infection (SSI), one of the important issues is managing the patient´s own skin flora. Many prophylactic initiatives have been suggested, including the use of IIID. IIID has been debated for many years and was deemed ineffective in preventing SSI in a recent systematic review [1], while some evidence suggests a potential increase in postoperative infection risk, as a result of IIID use [2].

IIID is sparsely investigated in orthopaedic surgery. An increase in the number of viable bacteria in the surgical field of an arthroplasty operation has a potential to increase the risk of SSI in an otherwise elective and clean procedure [3].

20 patients scheduled for TKA were recruited. Each patient had one knee randomized for draping with IIID [4] while the contralateral knee was left bare, thus the patients acted as their own controls. Operating theater settings with laminar airflow and standard perioperative procedures were simulated. Sampling was performed with the cup-scrup technique [5] using appropriate neutralizers. Samples were collected from the skin of each knee prior to disinfection and on 2 occasions after skin-preparation, 75 minutes apart. Bacterial quantities were estimated by spread plating with 48-hour aerobic incubation. Outcome was measured as colony forming units per square centimeter of skin. We used Wilcoxon signed-rank test for comparative analysis within and between knees.

Following skin-disinfection we found no significant difference in bacterial quantities between the intervention and the control knee (p = 0.388). Neither did we see any difference in bacterial quantities between the two groups after 75 minutes of simulated surgery (p = 0.367). When analyzed within the intervention and control group, bacterial quantities had not significantly increased at the end of surgery when compared to baseline, thus no recolonization was detected (p = 0.665 and 0.609, respectively).

Iodine impregnated incision drapes did not increase bacterial recolonization rates in simulated TKA surgery. Thus, the results of this RCT study does not support the hypothesis that iodine impregnated incision drapes promotes bacterial recolonization and postoperative infection risk.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_II | Pages 213 - 213
1 Jul 2008
Wies JT Humphreys H Latham M Enrico P Viljoen T Hazleman B Speed C
Full Access

The purpose of this study was to assess the efficacy of physiotherapy approaches to treatment of rotator cuff tendinopathies (RCT). Ninety shoulders were randomised in the study. A power calculation performed demonstrated using a factorial study design, 85 shoulders would be needed for 80% power at 95% confidence. All participants gave informed consent and ethical approval was granted by the Cambridge LREC. The primary outcome measure was the Shoulder Pain and Disability Index. Participants were blinded to their allocation and were randomised to one of four groups: Therapeutic Exercise(T), Manual Therapy(M), combined T/M (X), or Placebo(P). Participants were seen for two baseline assessments with a 4-week interval and then randomised. Final assessments were performed one week after the last session. The analysis involved a comparison between groups in change from baseline SPADI using ANCOVA adjusting for baseline scores. This involved testing for any interaction between M and T, and subsequently testing for main effects of M and T. Adjusted baseline and final SPADI scores (SD) by group were: X 41.6(15.4), 21.1(20.8); T 47.6(19.3), 26.3(14.7); M 44.1(17.9), 33.1(23.3); and P 39.5(24.7), 36.6(30.6). The main effects (with Significance, Standard Error and Confidence Interval) by group were: Baseline=0.686 (SE=0.104;CI=0.479,0.892); T=−13.347 (p=0.002;SE=4.091;CI=−21.479,−5.215); X=5.479 (p=0.510;SE=8.284; CI=−10.991,21.950); M=−4.126 (p=0.314;SE=4.077;CI=−12.230,3.978). A statistically significant reduction in SPADI was observed for the T group alone. There was no significant interaction effect with the addition of manual therapy and the M group did not improve significantly. It appears that best practice for treatment of RCT should centre around therapeutic exercise.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_9 | Pages 20 - 20
1 Feb 2013
Tasker A Hassaballa M Lancaster S Murray J Porteous A
Full Access

We present a prospective, randomised, single-centre, multi-surgeon, controlled trial comparing minimally invasive (MIS) and standard approach total knee arthroplasty (TKA).

86 patients undergoing 92 total knee replacements were recruited. 46 operations were randomised to the MIS treatment arm, 46 to the standard control arm. Data collected included postoperative blood loss, length of stay and complications. Patients underwent surgery via a quadriceps sparing or standard medial parapatella approach. All operations were performed using MIS instruments and an identical postoperative care pathway.

The MIS group had a significantly shorter length of stay (1.4 days, p=0.004) and fewer complications (p=0.003). Demographics, operative time blood loss and radiographic alignment were comparable between the groups. There were no deaths, pulmonary emboli or surgical site infections. 1 patient developed DVT and 1 required revision for pain and failure to regain flexion within 9 months of surgery, both in the control group. Nine percent of MIS patients versus 35% controls suffered a complication delaying discharge, of which 2% and 17% related to surgical site problems respectively.

MIS resulted in a shorter admission and fewer complications, whilst achieving satisfactory component alignment. We discuss the potential economic implications.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_13 | Pages 17 - 17
1 Jun 2016
Akhbari P Jaggard M Hillier V Abhishetty N Lahoti O
Full Access

Congenital talipes equinovarus (CTEV) is a complex three-dimensional deformity with an incidence of 1–3 per 1000 live births. The Ponseti method is widely accepted and practiced, giving reliably good long-term results. There are a number of studies showing the benefits of a physiotherapy led Ponseti service with outcomes similar to a consultant led service. We present the first prospective randomised series comparing a physiotherapy led Ponseti service with a standard orthopaedic surgeon led series.

16 infants with bilateral CTEV were randomised into two groups. Each infant had one foot treated by a physiotherapist and the other foot treated by an orthopaedic surgeon using the Ponseti technique. Both groups had a premanipulation Pirani score of 5.5. All patients were followed up for a minimum of 12 months and the results demonstrated no significant difference in the post-treatment Pirani scores (p=0.77) and no significant difference in the success rate the Ponseti technique (p=1.00).

This study is the first of its kind and demonstrates the value of a physiotherapy led Ponseti service in the management of CTEV. Although overall supervision by a paediatric orthopaedic surgeon is still necessary, this service will allow the surgeon to spend more time dealing with more complex problems.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 57 - 57
1 Dec 2016
Laende E Dunbar M Richardson G Reardon G Amirault D
Full Access

The trabecular metal Monoblock TKR is comprised of a porous tantalum base plate with the polyethylene liner embedded directly in the porous metal. An alternative design, the trabecular metal Modular TKR, allows polyethylene liner insertion into the locking base plate after base plate implantation, but removes the low modulus of elasticity that was inherent in the Monoblock design. The purpose of this study was to compare the fixation of the Monoblock and Modular trabeucular metal base plates in a randomised controlled trial.

Fifty subjects (30 female) were randomly assigned to receive the uncemented trabecular metal Monoblock or uncemented trabecular metal Modular knee replacement. A standard procedure of tantalum marker insertion in the proximal tibial and polyethylene liner was followed with uniplanar radiostereometric analysis (RSA) examinations immediately post-operatively and at 6 week, 3 month, 6 month, and 12 month follow-ups. The study was approved by the Research Ethics Board and all subjects signed an Informed Consent Form.

Twenty-one subjects received Monoblock components and 20 received Modular components. An intra-operative decision to use cemented implants occurred in 5 cases and 4 subjects did not proceed to surgery after enrollment. The clinical precision of implant migration measured as maximum total point motion (MTPM) was 0.13 mm (upper limit of 95% confidence interval of double exams). Implant migration at 12 months was 0.88 ± 0.64 mm (mean and standard deviation; range 0.21 – 2.84 mm) for the Monoblock group and 1.60 ± 1.51 mm (mean and standard deviation; range 0.27 – 6.23 mm) for the Modular group. Group differences in 12 month migration approached clinical significance (p = 0.052, Mann Whitney U-test).

High early implant migration is associated with an increased risk for late aseptic loosening. Although not statistically significant, the mean migration for the Modular component group was nearly twice that of the Monoblock, which places it at the 1.6 mm threshold for “unacceptable” early migration (Pijls et al 2012). This finding is concerning in light of the recent recall of a similar trabecular metal modular knee replacement and adds validity to the use of RSA in the introduction of new or modified implant designs.

Reference: Pijls, B.G., et al., Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop, 2012. 83(6): p. 614–24.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_23 | Pages 57 - 57
1 Dec 2016
Rezapoor M Tan T Maltenfort M Chen A Parvizi J
Full Access

Aim

Different perioperative strategies have been implemented to reduce the devastating burden of infection following arthroplasty. The use of iodophor-impregnated adhesive incise drapes is one such strategy. Despite its wide adoption, there is little proof that this practice leads to a reduction of bacterial colonization. The aim of this randomized, prospective study was to evaluate the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count at the incision site.

Method

A total of 96 patients undergoing open joint preservation procedure of the hip were enrolled in this prospective, randomized clinical trial of iodophor-impregnated adhesive drapes*. One half of patients (n=48) had iodophor-impregnated adhesive drapes* applied to the skin prior to incision and kept on throughout the procedure, while the other half (n=48) underwent the same surgery without the use of iodophor-impregnated adhesive drapes*. Culture swabs were taken from the surgical site at five different time points during surgery (pre-skin preparation, after skin preparation, post-incision, before subcutaneous closure, and prior to dressing application) and sent for culture and colony counts. Mixed-effects and multiple logistic regression analyses were utilized.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_10 | Pages 24 - 24
1 Oct 2015
Rajkumar S Thiagaraj S Ghoz A Dodds R Tavares S
Full Access

In a prospective randomised controlled trial, 51 patients who did not receive a bone plug during total knee replacement surgery were compared to 49 patients who received a bone plug. The primary outcome measure was the need for allogenic blood transfusion requirement and the secondary outcome was the post-operative blood loss and decline in haemoglobin levels. The patients had autologous re-transfusion from their closed drainage system. The two groups did not differ in the demographics. The mean intra-operative blood loss was slightly more in the no plug group (difference of 41.25 millilitres), which was not statistically significant. There was no statistically significant difference in total post-operative blood loss and drop in haemoglobin levels. Only one patient had two units of allogenic blood transfusion in the no bone plug group while none required allogenic blood in the bone plug group. There was no statistically significant difference in the amount of blood re-transfused from the drain between the two groups. Our findings did not show any statistically significant difference in post-operative blood loss, decline in haemoglobin levels and the need for allogenic blood transfusion in total knee replacement surgery.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 34 - 34
1 Jan 2014
Refaie R Chong M Murty A Reed M
Full Access

Introduction:

Symptomatic treatment of ankle osteoarthritis (OA) with corticosteroid injections is well established. Hyaluronic acid is also reported as an effective symptomatic treatment for ankle OA but these two treatments have not been compared directly.

Methods:

A prospective randomised controlled trial in patients with symptomatic ankle osteoarthritis. Twenty patients per group were required based on a significance level of 0.05, and a drop out rate of 5%. Patients were blindly allocated to the treatment or control group. Injections were carried out by the clinician in the outpatient department. Treatment group received Ostenil 20 mg and control group received Depomedrone 40 mg (both as single injections). The treatment arm was allocated by computer generated block randomization to match treatment allocation with grade of arthritis. The primary outcome measure was the change in Visual Analogue Scale (VAS) pain score at 6 months. Secondary outcome was the change in AOFAS score at 6 months. Research ethics committee approval was obtained.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 556 - 556
1 Oct 2010
Parker M
Full Access

A hip fracture may lead to anaemia after surgery due to blood loss from the fracture site and operative blood loss. The value of iron supplementation for this group of patients remains controversial. A randomised trial was undertaken for 300 patients who had a haemoglobin of less than 110g/l after surgery. Patients were randomised to take either ferrous sulphate, (200mg twice daily for four weeks) or had no iron therapy. Patients were followed up to one year after surgery.

The mean age of patients was 82 years. 19% were male. The mean difference between admission haemoglobin and the haemoglobin taken 6 weeks after discharge was 7.3g/l in the iron supplementation group and 8.3g/l in the group that did not receive iron supplementation (p value 0.5). There was also no statistically significant difference between groups for hospital stay (19 versus 21 days) or mortality. 18% of those allocated to iron therapy reported side effects from the medication.

This study indicates that routine oral iron supplementation for anaemia after hip fracture surgery is not appropriate.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 39 - 39
1 Aug 2012
Alvand A Auplish S Gill H Rees J
Full Access

Background

The ability to learn arthroscopic surgery is an important aspect of modern day orthopaedic surgery. Knowing that variation in innate ability exists amongst medical students, the aim of this study was to investigate the effect of training on the arthroscopic surgical performance of our future orthopaedic surgeons (medical students).

Methods

Two arthroscopic tasks (one shoulder and one knee) were set up in a bioskills laboratory to represent core skills required for arthroscopic training. Thirty three medical students with no previous arthroscopic surgery experience were randomised to a ‘Trained’ (n=16) and ‘Non-trained’ (n=17) cohort. Both groups watched an instructional video. The Trained cohort also received specific training on the tasks prior to their first episode. Thirty episodes of each task were then undertaken. The primary outcome variable was success or failure. Individuals were assessed as ‘competent’ if they stabilised their learning curve within 20 episodes. The secondary outcome measure was an objective assessment of technical dexterity using a validated Motion Analysis system (time taken to complete tasks, total path length of the subject's hands, and number of hand movements).


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 181 - 181
1 Mar 2006
Zacharopoulos A Vasiliets T Apostolopoulos A Crisanthopoulou M Anastasopoulos P Antoniou D Xenos G Moscachlaidis S
Full Access

Purpose: The purpose of our study, is to determine the role of erythropoetin administration, as an alternative to homologous banked blood transfusions in total hip arthroplasty.

Material and Methods: We have carried out a prospective randomized, controlled study on 60 patients having unilateral total hip replacement. In all the above patients, the same surgical team applied the same surgical technique (hybrid THA) and they followed the same rehabilitation program. We examined 2 groups of patients. In group A, all the patients received intraoperatively one unit of homologous blood transfusion (average 1 unit/patient), according to the volume of blood collected in the suction device and to the anaesthesiologist’s estimation. We also administered 40,000 units of erythropoetin subcutaneously one day before the operation followed by 40,000 units (sc) every 3 days in a total scheme of 4 doses. A control group of 30 patients (group B), in whom standard suction drains were used, received intraoperatively one or two units of homologous blood transfusion (average 1,7 units/patient), and also additional blood transfusions when required. The admission of banked blood transfusion was determined by the Haemoglobin value (< 9mg/dl) and/or clinical signs (blood pressure, pulse etc.). The values of Haemoglobin, Haematocrit and Platelets were recorded preoperatively and the 1st, 5th, and 15th day postoperatively.

Results: 5 patients of group A required postoperatively 7 units of homologous blood (0,23 unit/patient) (total amount for group A 37 banked blood units 1,12 units/patient). 21 patients of group B required additional 28 banked blood units postoperatively (totally 79 banked blood units, or 2,63 units/patient). In the group A (study group), the total homologous blood requirements were reduced by 53%, the postoperative blood requirements were reduced by 75% and the number of patients that required additional blood transfusion was reduced by 67%. There was no significant difference noticed in the postoperative values of Haematocrit and Haemoglobin.

Conclusions: The use of erythropoetin reduces effectively the postoperative demands of homologous banked blood transfusion in total hip arthroplasty.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 99 - 100
1 Mar 2006
Newman J Ackroyd C Evans R
Full Access

Introduction. There has been a recent major increase in the use of unicompartmental knee replacement (UKR) but few studies exist comparing its long term efficiency with total knee replacement (TKR)

Method. Ethical approval was obtained.

Between 1989 and 1992 a randomised prospective study was undertaken in which 102 cases adjudged suitable for UKR were allocated to receive either a St Georg Sled UKR or a Kinematic Modular TKR. Both cohorts had a median age of 68 and a similar sex distribution and preoperative knee score. Regular follow up has been maintained. As reported the early results favoured UKR. All cases have now been assessed after a minimum of 10 years using modified WOMAC, Oxford and Bristol Knee Scores (BKS) as well as radiographs.

Results. 28 cases had died with their knees known to be intact, 2 cases were untraceable. 33 knees in each group were reviewed. 3 in each group had been revised, no impending failures were identified on the radiographs.

At 10 years the UKR group had better Oxford and WOMAC scores as well as significantly more excellent results (19:14) and fewer fair and poor results on the BKS. Both groups averaged over 105′ of flexion but 61% of the UKR and only 15% of the TKR group had 120′ or more of flexion.

Conclusion. The faster rehabilitation and better early results with UKR are maintained for 10 years with few failures occurring. The average BKS of the UKR group only fell from 91 to 88 between 5 and 10 years suggesting minimal evidence of functional deterioration in either the prosthesis or the remainder of the joint.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVIII | Pages 44 - 44
1 Jun 2012
Smith J Hussain S Horey L Patil S Meek R
Full Access

Hip resurfacing has generally been used in younger patients with early osteoarthritis of the hip. There has been considerable recent interest in this over the past few years. We conducted a prospective randomised trial comparing 2 hip resurfacing implants, Durom and ASR looking at radiological and clinical outcomes.

Forty-nine patients (78% male) with hip osteoarthritis which met the criteria for hip resurfacing were randomised to receive either a Durom or ASR resurfacing implant. These patients have so far been followed up for a minimum of one year. The groups were comparable in age (p=0.124) and gender (p=0.675). The average age in the ASR group was 54.04 years and in the Durom group it was 51.25.

Radiological views were scrutinised immediately post op and at final follow up so far to look at cup inclination, stem-shaft angle, and acetabular osseointegration.

Clinical outcomes were compared using the Oxford hip scores, WOMAC scores and SF12 scores.

At minimum follow up of 1 year the mean post operative Oxford hip score was not significantly different between the Durom (45.32, SD 3.93) and ASR (43.44, SD 8.44). The mean post operative WOMAC score was also not significantly different between the Durom (52.56, SD 6.06) and ASR (49.63, SD 2.23). There was no difference between the groups with regards to signs of osseointegration from radiological assessment (p=0.368). There were 3 periprosthetic femoral neck fractures (5.7%) and one revision for pain.

We conclude from this trial that there is no difference in the clinical or radiological findings between the Durom and ASR implants.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 343 - 343
1 Sep 2005
Ackroyd C Newman J Evans R
Full Access

Introduction and Aims: There has recently been an increase in the use of uni-compartmental knee replacement (UKR), but there are few studies comparing its long-term efficacy and survival with total knee replacement (TKR). We reported the five-year results of a randomised trial which showed that uni-compartmental replacement had a faster rehabilitation and better functional results than total replacement. We now report the 10-year results.

Method: After obtaining ethical approval, between 1989 and 1992, 102 cases judged suitable for UKR were randomly allocated to receive either a St Georg Sled UKR or a Kinematic Modular TKR. Both cohorts had a median age of 68 and a similar sex distribution and pre-operative knee scores. Regular follow-up has been maintained. All cases have now been assessed after a minimum of 10 years using modified the WOMAC, Pain, Oxford and Bristol Knee (BSK) scoring systems as well as radiographs.

Results: At 10 years, 29 cases had died with their knees known to be intact, two totals cases were untraceable. Thirty-two uni`s, and 34 totals were available for review. Three uni`s (6%) and two totals (4%) had been revised; there was one impending total failure on the radiographs.

The UKR group had better scores with Oxford: 38 v 34 /48 and WOMAC: 17 v 21 /60 and more excellent results (19 v 14) and fewer fair and poor results on the BKS (4 v 6). The range of movement improved in UKA`s from 107 degrees to 117 degrees, whereas the range decreased in TRK`s from 107 degrees to 104 degrees. Sixty-one percent of the UKR and only 16% of the TKR group had more than 120 degrees of flexion.

Conclusion: The St Georg Uni-compartmental arthroplasty continues to function well at 10 years, with better functional scores and a better range of movement than the Kinematic Total arthroplasty. There were similar failures in both groups.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 5 - 5
1 Mar 2012
Cole A Newsome R Chiverton N Breakwell L
Full Access

Objective

To investigate, through a randomised, single blind, Quasi-experimental trial, whether immediate physiotherapy after lumbar micro-discectomy enables patients to become independently mobile more rapidly with no increase in risk of complications.

Background data

Although studies have demonstrated the efficacy of rehabilitation after lumbar discectomy, nos have looked at physiotherapy commencing immediately post-operatively.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_III | Pages 63 - 63
1 Feb 2012
Cumming D Parker M
Full Access

The two commonest types of hemiarthroplasty used for the treatment of a displaced intracapsular fracture are the uncemented Austin Moore Prosthesis and cemented Thompson hemiarthroplasty. To determine if any difference in outcome exists between these implants we undertook a prospective randomised controlled trial of 300 patients with a displaced intracapsular hip fractures.

All operations were performed or supervised by one orthopaedic surgeon and all by a standard anterolateral approach. Patients were followed by a nurse blinded in the type of prosthesis to assess residual pain and mobility.

The average age of the patients was 83 years and 23% were male. 73% came from their own home with the remainder from institutional care. There was no statistically significant difference in mortality between groups, with 34/151 having died at one year in the cemented group and 45/149 in the uncemented group. Pain scores (grade 1-6) were less for those treated by a cemented prosthesis (mean score 1.8 versus 2.4, p value <0.00001). Mobility change was also less for those treated with a cemented implant (p=0002). No difference was found in hospital stay. Operative complications are as listed. One case of non-fatal intraoperative cardiac arrest occurred in the cemented group.

In summary a cemented Thompson Hemiarthroplasty causes less pain and less deterioration in mobility compared to uncemented Austin Moore hemiarthroplasty, without any increase in complications. The continued use of an uncemented Austin Moore cannot be recommended.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 405 - 405
1 Sep 2009
Khan R Haebich S Maor D
Full Access

Despite initial enthusiasm for minimally invasive total hip replacements (THR), there has been a marked paucity of level 1 evidence studies assessing it.

100 patients fulfilling the inclusion criteria were randomised in theatre to a standard posterior or muscle-sparing short incision (MIS) approach. A hybrid hip replacement was used routinely. Post-operative management was the same. Follow-up occurred at 2, 6 and 12 weeks. Patients, as well as functional and radiographic assessors were blinded.

50 patients were recruited to each group. There was no difference in demographics Mean incision length was 12.8cm and 19.1cm respectively. There was no statistically significant difference in operation time, post-op functional recovery (ILOA score) or length of stay. Pain (VAS) was similar post-operatively, and at 6 and 12 weeks. There was no significant difference in 10 metre walking speed or 6 minute walking distance at 2, 6 or 12 weeks; nor was there a difference in Oxford hip score, patient satisfaction with surgery (VAS), or SF-12 score at 6 or 12 weeks. Blood loss, fall in haematocrit, transfusion rate and CRP rise were similar. There was no significant difference in cementation of the stem (Barrack) or cup position (Dorr). There was one death from PE in the MIS group and one deep infection in the standard group. There was one dislocation in the standard group. The only statistical difference between the groups was less dependence on walking aids at 2 and 6 weeks in the MIS group; there was no difference at 12 weeks.

MIS surgery is safe, and may allow earlier independent mobility after THR. However, the claims of significantly reduced pain, less morbidity, better function and improved patient satisfaction appear to be unfounded.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 412 - 412
1 Sep 2009
Pandit H Jenkins C Beard D Gill H Marks B Price A Dodd C Murray D
Full Access

Introduction: The information in the literature about the relative merits of cemented and cementless unicompartmental knee replacement (UKR) is contradictory, with some favouring cementless fixation while others favouring cemented fixation. Cemented fixations give good survivorship but there is concern about the radiolucency which frequently develops around the tibial component. The exact cause of the occurrence of radiolucency is unknown but according to some, it may suggest suboptimal fixation.

Method: Sixty-two knees (31 in each group) were randomised to receive either cemented or cementless UKR components. The components were similar except that the cementless had a porous titanium and hydroxyappatite (HA) coating. Patients were prospectively assessed by an independent observer pre-operatively and annually thereafter. The clinical assessment included Oxford Knee Score, Knee Society Scores and Tegner activity score. Fluoroscopically aligned radiographs were assessed for thickness and extent of radiolucency under the tibial implant.

Results: At one year there were no differences in the clinical outcome between the groups and there were no loose components. No radiolucencies thicker than 1mm were seen. At one year none of the cementless tibias and 30% of the cemented tibias had complete radiolucencies. One out of 31 cementless (3%) and 12 out of 31 cemented (39%) had partial radiolucencies. This difference between these two groups was high significant (p< 0 0001).

Conclusions: This study clearly demonstrates that the incidence of radiolucency beneath the tibial component is influenced by component design and method of fixation. With identical designs of tibial component none of the cementless components developed complete radiolucences whereas 30% of the cemented components did. We conclude that HA achieves better bone integration than cement.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 80 - 80
1 Jan 2016
Tsukada S Wakui M Ooiwa M Tsurumaki K Hoshino A
Full Access

Background

Evidence from recent trials has supported the efficacy of periarticular analgesic injection for pain control following total knee arthroplasty (TKA). However, no randomized controlled trial has compared the efficacy of periarticular analgesic injection with that of other regimens for simultaneous bilateral TKA.

Methods

We conducted a randomized controlled trial in which patients scheduled for simultaneous bilateral TKA were randomly assigned to receive periarticular analgesic injection or epidural analgesia. In the periarticular analgesic injection group, the injection contained 7.5 mg/ml ropivacaine 40 ml, 10 mg/ml morphine hydrochloride hydrate 1.0 ml, 1.0 mg/ml epinephrine 0.6 ml, methylprednisolone 80 mg, and ketoprofen 50 mg. These agents were mixed with normal saline to a combined volume of 120 ml. The 60 ml of the cocktail was injected into each knee. In the epidural analgesia group, the catheter was placed at the L2–3 or L3–4 level, and connected to an infusion pump delivering continuous infusion (flow rate: 4 ml/h) of 100 ml of 2 mg/ml ropivacaine plus 1.0 ml of 10 mg/ml morphine hydrochloride hydrate. Surgery was managed under spinal anaesthesia. Surgical techniques and postoperative medication protocols were identical in both groups. The primary endpoint was postoperative pain at rest, quantified as the area under the curve (AUC) of the score on a visual analogue scale.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 284 - 284
1 Nov 2002
Vendittoli P
Full Access

Introduction: The excellent results obtained with metal-polyethylene (M-P) bearing surfaces in total hip arthroplasty (THA) are still limited by the production of polyethylene wear debris, osteolysis and aseptic loosening. Because of its superior tribologic properties and biologically inert composition, alumina-alumina (AL-AL) bearing surfaces are proposed to improved survival of THA but previously reported early complications prevented widespread use of this material.

Aim: To compare the early results and complications with Ceraver M-P and AL-AL THA.

Methods: One hundred and thirty-eight Ceraver hybrid THAs in patients less than 70 years old were randomised to M-P or AL-AL bearing surfaces. We present the clinical and radiological results for patients followed-up from six to 48 months.

Results: No significant difference was found on W.O.M.A.C. and Merle D’ Aubigné Postel scores. No specific complication associated with alumina components like fracture or malpositioning of the acetabular insert were observed in this study. Documented complications were: infection 3 AL-AL / 0 M-P; dislocation 1 AL-AL / 4 M-P; and heterotopic ossification 47% AL-AL / 24% M-P. No aseptic loosening was observed.

Discussion and Conclusion: Ceraver AL-AL bearing surfaces gave early clinical and radiological results similar to M-P. Our results were in accordance with studies suggesting that AL-AL has the potential to become the bearing surfaces of choice in THA in the young patients.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 113 - 113
1 Jan 2017
Boriani F Granchi D Roatti G Merlini L Sabattini T Baldini N
Full Access

The postoperative course of median nerve decompression in the carpal tunnel syndrome may sometimes be complicated by postoperative pain, paresthesias, and other unpleasant symptoms, or be characterized by a slow recovery of nerve function due to prolonged preoperative injury causing extensive nerve damage.

The aim of this study is to explore any possible effects of alpha lipoic acid (ALA) in the postoperative period after surgical decompression of the median nerve at the wrist.

Patients were enrolled with proven carpal tunnel syndrome and randomly assigned into one of two groups: Group A: surgical decompression of the median nerve followed by ALA for 40 days. Group P: surgical decompression followed by placebo. The primary endpoint of the study was nerve conduction velocity at 3 months post surgery, Other endpoints were static 2 point discrimination, the Boston score for hand function, pillar pain and use of pain killers beyond the second postoperative day.

ALA did not show to significantly improve nerve conduction velocity or Boston score. However, a statistically significant reduction in the postoperative incidence of pillar pain was noted in Group A. In addition, static 2 point discrimination showed to be significantly improved by ALA.

Administration of ALA following decompression of the median nerve for carpal tunnel release is effective on nerve recovery, although this is not detectable through nerve conduction studies but in terms of accelerated and improved static two-point discrimination.

The use of ALA as a supplementation for nerve recovery after surgical decompression may be extended to all types of compression syndromes or conditions where a nerve is freed from a mechanical insult.

Furthermore, ALA limits post-decompression pain, including late pericicatricial pain at the base of the palm, the so called pillar pain, which seems to be associated with a reversible damage to the superfical sensitive small nerve fibers.

In conclusion postoperative administration of ALA for 40 days post-median nerve decompression was positively associated with nerve recovery, induced a lower incidence of postoperative pillar pain and was associated with a more rapid improvement of static two-point discrimination. This treatment is well tolerated and associated with high levels of satisfaction and compliance, supporting its value as a standard postoperative supplementation after carpal tunnel decompression.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 70 - 70
1 Jan 2017
Wylde V Marques E Artz N Blom A Gooberman-Hill R
Full Access

Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times for THR can be considerable, and patients often experience significant pain during this time. A pain self-management intervention may provide patients with the skills to enable them to manage their pain and its impact more effectively before surgery. However, studies of arthritis self-management programmes have faced challenges because of low recruitment rates, poor intervention uptake, and high attrition rates. This study aimed to evaluate the feasibility of a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Specific objectives were to assess trial design, ascertain recruitment and retention rates, identify barriers to participation, refine data collection methods, and evaluate uptake and patient satisfaction with the course.

Patients listed for THR in an elective orthopaedic centre Bristol, UK were sent a postal invitation about the study. Participants were randomised to attend a pain self-management course plus standard care or standard care only using a computer-generated randomisation system. The pain self-management course was delivered by Arthritis Care and consisted of two half-day group sessions prior to surgery and one full-day group session 2–4 months after surgery. A structured course evaluation questionnaire was completed by participants.

Outcomes assessment was by postal questionnaire prior to surgery and 1-month, 3-months and 6-months after surgery. Self-report resource use data were collected using a diary prior to surgery and inclusion of resource use questions in the 3-month and 6-month post-operative questionnaires. Brief telephone interviews were conducted with non-participants to explore barriers to participation.

Postal invitations were sent to 385 eligible patients and 88 patients consented to participate (23% recruitment rate). Participants had a mean age of 66 years and 65% were female. Brief interviews with 57 non-participants revealed the most common reasons for non-participation were perceptions about the intervention and difficulties in getting to the hospital for the course.

Of the 43 patients randomised to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and patients enjoyed the group format.

Retention of participants was acceptable, with 83% completing follow-up. Questionnaire return rates were high (76–93%), with the exception of the pre-operative resource use diary (35%). Completion rates for the resource use questions varied by category and allowed for an economic perspective from the health and social care payer to be taken.

Undertaking feasibility work for a RCT is labour-intensive; however this study highlights the importance of conducting such work. Postal recruitment resulted in a low recruitment rate and brief interviews with non-participants provided valuable information on barriers to participation. Embedding collection of resource use data within questionnaires resulted in higher completion rates than using resource use diaries. While patients who attended the course gave positive feedback, attendance was low. Findings from this feasibility study enable us to design successful definitive group-based RCTs in the future.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_14 | Pages 18 - 18
1 Jul 2016
Roberts V Attwall M Fombon F Bhatia M
Full Access

Osseous first ray surgery is a common day case procedure. Patients are often given regional blocks. We sought to find if there is a difference between ankle block and metatarsal block in this group of patients. After ethical approval was granted and power analysis performed, 25 patients were recruited into each arm of the study. These patients were having either an osteotomy or arthrodesis.

All patients had standardised general anaesthesia and received 20mls of 0.5% chirocaine for the blockade. The cohort having the ankle block had infiltration under ultrasound guidance in the anaesthetic room; and the cohort receiving the metatarsal block had infiltration at the end of the procedure. The timings of both the anaesthesia and the operation were recorded for each patient.

Patients scored their pain level at 2, 6 and 24 hours. The amount of post-operative analgesia used in the first 24 hours was also recorded by the research nurse. All patients were discharged home with a standardised prescription of analgesia.

Analysis of the pain scores showed that there was no difference between the two blocks at any measured time period. Nor was there a difference in the analgesic requirement in the first 24 hours. There was, however, a difference in the time taken for the whole procedure: with the ankle block taking an average of ten minutes more.

We conclude that metatarsal blocks are as effective as ankle blocks in providing pain relief after osseous first ray surgery, and may be a more efficient use of time.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 308 - 308
1 Mar 2013
Jenkins D Rodriguez J Ranawat A Alexiades M Deshmukh A Rathod P McHugh M
Full Access

Introduction

Patellar mobilisation methods used during total knee arthroplasty (TKA) have been debated in the literature, with some proponents of minimally invasive TKA suggesting that laterally retracting, rather than everting the patella may be beneficial. It was our hypothesis that by using randomised, prospective, blinded study methods, there would be no significant difference in clinical outcome measures based solely on eversion of the patella during total knee arthroplasty.

Methods

After an a priori power analysis was done, 120 primary total knee replacements indicated for degenerative joint disease were included in the study and randomised to one of two patella exposure techniques: lateral retraction or eversion. Short-term outcomes were evaluated during hospitalisation and included time to return of straight leg raise (SLR), ambulation distance, and length of hospital stay. Long-term outcome values were evaluated pre-operatively, at 6 weeks, 3 months, and 1 year post-operatively, and included leg extension strength measured by dynamometer, knee range of motion (ROM), Visual Analog Scale (VAS) pain before and after knee motion, circumferential thigh measurements, and SF-36 Physical and Mental Component Scores (PCS, MCS). All collaborating investigators were blinded to each other's data. Surgical techniques and perioperative arthroplasty management protocols were those routinely and currently used during total knee replacement surgery at our institution.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 114 - 120
1 Feb 2024
Khatri C Metcalfe A Wall P Underwood M Haddad FS Davis ET

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies. Cite this article: Bone Joint J 2024;106-B(2):114–120


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 93 - 93
1 Dec 2016
Mulpuri K Dobbe A Schaeffer E Miyanji F Alvarez C Cooper A Reilly C
Full Access

Closed reduction and percutaneous pinning has become the most common technique for the treatment of Type III displaced supracondylar humerus fractures in children. The purpose of this study was to evaluate whether the loss of reduction in lateral K wiring is non-inferior to crossed K wiring in this procedure.

A prospective randomised non-inferiority trial was conducted. Patients aged three to seven presenting to the Emergency Department with a diagnosis of Type III supracondylar humerus fracture were eligible for inclusion in the study. Consenting patients were block randomised into one of two groups based on wire configuration (lateral or crossed K wires). Surgical technique and post-operative management were standardised between the two groups. The primary outcome was loss of reduction, measured by the change in Baumann's angle immediately post –operation compared to that at the time of K wire removal at three weeks. Secondary outcome data collected included Flynn's elbow score, the humero-capitellar angle, and evidence of iatrogenic ulnar nerve injury. Data was analysed using a t-test for independent means.

A total of 52 patients were enrolled at baseline with 23 allocated to the lateral pinning group (44%) and 29 to the cross pinning group (56%). Six patients (5 crossed, 1 lateral) received a third wire and one patient (crossed) did not return for x-rays at pin removal and were therefore excluded from analysis. A total of 45 patients were subsequently analysed (22 lateral and 23 crossed). The mean change in Baumann's angle was 1.05 degrees, 95% CI [-0.29, 2.38] for the lateral group and 0.13 degrees, 95% CI [-1.30, 1.56] for the crossed group. There was no significant difference between the groups in change in Baumann's Angle at the time of pin removal (p = 0.18). Two patients in the crossed group developed post-operative iatrogenic ulnar nerve injuries, while none were reported in the lateral group.

Preliminary analysis shows that loss of reduction in Baumann's angle with lateral K wires is not inferior to crossed K wires in the management of Type III supracondylar humerus fractures in children. The results of this study suggest that orthopaedic surgeons who currently use crossed K wires could consider switching to lateral K wires in order to reduce the risk of iatrogenic ulnar nerve injuries without significantly compromising reduction.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 3 - 3
1 Feb 2018
Cherkin D Hill J Sowden G Foster N
Full Access

Purpose & Background

The STarT Back risk-stratification approach uses the STarT Back Tool to categorise patients with low back pain (LBP) at low, medium or high-risk of persistent disabling pain, in order to match treatments. The MATCH trial (NCT02286141) evaluated the effect of implementing an adaptation of this approach in a United States healthcare setting.

Methods

This was a pragmatic cluster randomised trial with a pre-intervention baseline period. Six primary care clinics were pair-randomised, three to an intensive stratified care quality improvement intervention and three as controls. LBP patients were invited to provide outcomes two weeks after their primary care visit, and two and six months later. Primary outcomes were physical function (RMDQ) and pain (0–10 NRS), and secondary outcomes including healthcare use and treatments provided received. Analysis was intention-to-treat.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 160 - 160
1 Sep 2012
Kuzyk PR Saccone M Sprague S Simunovic N Bhandari M Schemitsch EH
Full Access

Purpose

Cross-linking of polyethylene greatly reduces its wear rate in hip simulator studies. We conducted a systematic review and meta-analysis of randomized controlled trials comparing cross-linked to conventional polyethylene liners for total hip arthroplasty to determine if there is a clinical reduction of: 1) wear rates, 2) radiographic osteolysis, and 3) need for total hip revision.

Method

A systematic search of MEDLINE, EMBASE, and COCHRANE databases was conducted from inception to May 2010 for all trials involving the use of cross-linked polyethylene for total hip arthroplasty. Eligibility for inclusion in the review was: use of a random allocation of treatments; a treatment arm receiving cross-linked polyethylene and a treatment arm receiving conventional polyethylene for total hip arthroplasty; and use of radiographic wear as an outcome measure. Eligible studies were obtained and read in full by two co-authors who then independently applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to each study. Pooled mean differences were calculated for the following continuous outcomes: bedding-in, linear wear rate, three dimensional linear wear rate, volumetric wear rate, and total linear wear. Pooled risk ratios were calculated for radiographic osteolysis and revision hip arthroplasty.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 388 - 388
1 Jul 2010
Cheung G Oakley J Bing A Carmont M Graham N Alcock R
Full Access

Introduction: Primary total hip replacement remains one of the commonest orthopaedic procedures performed. It is yet to be clearly demonstrated whether use of a postoperative drain is of benefit in these procedures.

Methods: We carried out a prospective randomised study comparing the use of autologous reinfusion drains, closed suction drains or no drain to determine their influence on allogenic blood transfusion requirements, length of hospital stay and infection rates. Stratification was carried out for confounding factors.

Results: 153 patients were recruited into the study and randomised to one of the three closely matched groups. There was no significant difference between the mean intra-operative blood loss or post-operative haemaglo-bin levels between the 3 groups. 42% of the suction drain group required post-operative transfusion as compared to 17% of the reinfusion drain group and 12% of the group with no drains. This difference was highly significant (P=0.02) Mean time for the wound to become dry was 3 days, 3.9 days and 4 days in the no drain, re-transfusion drain and suction drain groups respectively. This difference was statistically significant (P=0.03). There was no statistically significant difference in the mean length of inpatient stay.

Discussion: This study demonstrates a significantly higher transfusion rate with closed suction drains compared to reinfusion drains or no drains. With the drive to reduce hospital stay our study supports the considered use of no drain or a reinfusion drain.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 414 - 414
1 Jul 2010
Patel NK Bucknill A Denning J Ahearne D Desai K Watson M
Full Access

Purpose: To determine if early MRI diagnosis in the acutely injured knee affects management, use of resources and patient satisfaction compared to conventional management with physiotherapy.

Methods: Patients referred to fracture clinic with acute knee injury in whom a specific clinical diagnosis could not be made were randomised to one of two groups. The MRI group had a scan within 2 weeks and were then reassessed in clinic with management according to the results. The control group received physiotherapy and then reassessed. Patients were assessed in clinic on presentation, at 2 weeks and then by a telephone questionnaire at 3 months. Electronic medical records were also reviewed.

Results: 48 patients were recruited in total: 23 in the MRI group (78.2% male, 21.8% female) and 25 in the control group (68% male, 32% female). The mean age was similar in the two groups (29 years (range 18–61) vs. 30 years (18–50)). The MRI group had significantly less physiotherapy appointments (5 ± 3.42 vs. 2.52 ±1.93, p=0.003) on average until definitive treatment but not outpatient appointments (2.72 ± 1.1 vs. 2.43 ±0.66, p=0.27). Median time to surgery was less in the MRI group (138 (31–199) vs.180 days (33–826) vs.) but not statistically significant (p=0.19). A similar number of patients returned to work in both groups (82.6% vs. 76%) but the MRI group had less time off work (15.82 ±22.26 vs. 20.56 ±25.38 days, p=0.48) and statistically better satisfaction scores (2 ±2.68 vs. 3.5 ±2.75, p=0.048) than the control group.

Conclusion: We have shown that early MRI in acute knee injury can provide early diagnosis of internal derangement and therefore allow targeted treatment. These patients had significantly less physiotherapy appointments and less time off work which may offset the cost of the MRI. Moreover these patients were significantly more satisfied with the service.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 153 - 153
1 Mar 2006
Lakshmanan P Ahuja S Davies P Howes J
Full Access

Introduction Local steroid injection is commonly performed as a treatment for facet joint arthritis in the lumbosacral spine. The injection is performed under image guidance for which some surgeons utilise antero-posterior (A-P) imaging only while others prefer oblique imaging. The entry point and the direction of the needle entering into the facet joint are different in these techniques. Further the difficulties encountered in both the techniques are different.

Purpose To find out the difference in the functional outcome in patients who received the facet joint steroid injection by A-P imaging and those who had the injection by oblique imaging.

Material and Methods A prospective randomised controlled trial was performed by randomly allocating the 20 patients who was diagnosed to have facet joint arthritis clinically and by magnetic reasonance image scans, and who were then placed in the list for facet joint injections. Ten patients in Group I received the facet joint injections with A-P imaging while 10 patients in Group II received the facet joint injections with oblique imaging using image intensifier. All the patients received 40mg of methylprednisolone acetate with 1mL of 1% lignocaine and 1mL of 0.5% bupivacaine to each joint. The duration of the entire procedure was noted. Short Form-36 (SF-36) questionnaire was used before the procedure and at six weeks after the procedure to assess the functional outcome.

Results All the patients were followed up for a period of six weeks. The mean age was 51.3 yrs in Group I and 48.3 yrs in Group II. The male to female ratio was 3:7 in Group I and 2:5 in Group II. One patient in Group I had the facet injections at only one level (L4/5 or L5/S1) while it was in two patients in Group II. Further one patient in Group I and one in Group two had unilateral facet joint injections at two levels. All the other patients had bilateral facet joint injections at two levels (L4/5 and L5/S1). One patient was excluded from the study as the A-P image obtained was very poor and that an oblique image had to be performed to visualise the facet joint because of obesity. The mean duration of the procedure was 18.33 min (10–25 min) in Group I and 22 min (10–35 min) in Group II (p=0.14, 95%CI −8.5 to +1.4). The patient function score improved from a mean of 20.0% to 32.5% after the injection in Group I, and from 30.0% to 41.0% in Group II. The pain score improved from a mean of 33.3% to 47.2% in Group I, and from 35.6% to 44.4% in Group II. The difference in physical function score (p=0.85, 95% C.I. −15.29 to +18.29), and pain score (p=0.71, 95% C.I. −24.21 to +34.22) between the two groups were not statistically significant.

Conclusions There is no difference in the functional outcome of patients treated by facet joint injections using A-P or oblique imaging. However, with experience we found that it may be difficult to visualise the facet joint clearly by A-P imaging alone in obese individuals.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVII | Pages 40 - 40
1 May 2012
O'Briain D Kelly J Kerin M Kearns S
Full Access

Introduction

Ischaemia reperfusion injury (IRI) is a very common metabolic insult in orthopaedics. It is often a subtle clinical event such as after brief tourniquet use, however severe injury, even multi-organ failure or death may result from prolonged tourniquet-use, crush injuries, vascular trauma or the release of compartment-syndrome. IRI is mediated by leukocyte infiltration and oxidatively-induced endothelial disruption. Antioxidants clearly attenuate or prevent this effect in animal models.

Hypothesis

That the antioxidant medications ascorbate and n-acetyl-cysteine attenuate IRI in the setting of elective knee arthroscopy.


Introduction

The mobile-bearings were introduced in total knee arthroplasty (TKA) to improve the knee performance by simulating more closely ‘normal’ knee kinematics, and to increase the longevity of TKA by reducing the polyethylene wear and periprosthetic osteolysis. However, the superiority between posterior-stabilized mobile-bearing and fixed-bearing designs still remains controversial. The objective of the present study was to compare the mid-term results of Scorpio + Single Axis system (Stryker Howmedica Osteonics, Allendale, New Jersey) for the mobile-bearing knees and Duracon system (Stryker Howmedica Osteonics, Allendale, New Jersey) for the fixed bearing design with regard to clinical and roentgenographic outcome with special reference to any complications and survivorship.

Methods

Prospective, randomized, double-blinded controlled study was carried out on 56 patients undergoing primary, unilateral total knee arthroplasty for osteoarthritis, who were divided into two groups. Group I received mobile-bearing knee prosthesis (29 patients) and Group 2 received fixed-bearing prosthesis (27 patients). The patients were assessed by a physical examination and knee scoring systems preoperatively, at a follow-up of three months, six months, and one year after surgery by independent researcher who was not part of the operating team, and was blinded as to the type of implant inserted. We used the Oxford knee score (OKS) and Knee society score (KSS), with Knee Society Knee Score (KSKS) and Knee Society Functional Score (KSFS) being the subsets. The questionnaire for OKS was printed in our national language, and handed over to the patient at each visit.


Introduction

Pain control following total knee arthroplasty (TKA) heavily influences timing of mobilization and rehabilitation postoperatively as well as length of hospital stay. Recently, periarticular injection of liposomal bupivacaine (EXPAREL®; Pacira Pharmaceuticals, Inc., San Diego, California) has demonstrated pain relief comparable to femoral nerve block for postoperative analgesia in TKA with earlier mobilization and shortened hospital stay. In order to better explore the use of EXPAREL® in TKA, we standardized the postoperative analgesia to intraoperative periarticular injection of multimodal pain management, which is a recommended postoperative method of pain control in TKA. We studied the effectiveness of periarticular EXPAREL® in TKA postoperative pain control, including impact on early mobilization and length of hospital stay, compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.

Methods

We performed a double blind, randomized, controlled, prospective, IRB-approved study that enrolled 96 participants who underwent a unilateral TKA by one surgeon between May 2014 and March 2015. The two randomized groups were as follows: group 1 (control group) was given the standard intra-articular “pain cocktail” injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation and group 2 (study group) was given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into an 80cc preparation as well as an injection of EXPAREL®, 20cc of 1.3% EXPAREL®, to total 100cc. All patients included in the study were determined to be opioid naïve as described by the Food and Drug Administration criteria. Patients were treated with the same postoperative pain management protocol as well as the same post-operative physical therapy program. The consumption of oral and intravenous narcotics at specific time points as well as total use was recorded during hospital stay. We recorded Visual Analog Pain scores, hours to ambulate 100 feet and length of hospital stay (hours). Both the investigator and the patient were blinded as to which group the patient was randomized, making this a double blind study.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_III | Pages 25 - 25
1 Feb 2012
Mishra V Wood P
Full Access

Methods

There were 106 men and 94 women (mean age 65 years; 22 - 85). 69 patients had inflammatory arthritis and 131 osteo-arthritis. 27 patients (13 B-P, 14 STAR) had a pre-operative varus/valgus deformity greater than or equal to 20 degrees. Mean follow-up was 48 months (36-72).

Results

Ten patients had died from unrelated cause with satisfactory final outcome assessment. Thirteen ankles (4 STAR, 9 B-P) required revision surgery. The causes of failure were: early deep infection (1 STAR), recurrent deformity (1 STAR, 4BP) aseptic loosening (1STAR, 4 BP), implant failure (1STAR, 1 BP). Six revised ankles (5BP, 1STAR) had pre-operative varus/valgus deformity of 20 degrees or more. AOFAS score for pain improved from 0 to 35 and for function from 30 to 43. There was no difference between the two groups. Pre-operative range of movement was predictive of the final range of movement. Radiographic assessment showed that 30 patients (17BP, 13 STAR) had recurrent deformity (edge loading) as shown by the UHMWPE insert no longer articulating congruently with the metallic components. 14 ankles (8BP, 6 STAR) from this group had pre-operative deformity of 20 degrees or more.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_II | Pages 90 - 90
1 Feb 2012
Cloke J Watson H Purdy S Steen I Williams J
Full Access

Shoulder pain represents a significant burden of disease in the general population, yet there is a lack of evidence about the effectiveness of routinely used interventions. Current management of ‘painful arc’ of the shoulder in Primary Care is not evidence-based.

Over a six-month period patients with ‘painful arc’ of less than six months duration were recruited via their GPs. Eligible patients were consented to enter the trial and were then randomised, by sealed envelopes, to one of four arms of the study: control (normal analgesia and/or non-steroidal anti-inflammatory medication), a specified and repeatable Exercise and Manual Therapy Package (EMTP), a course of up to three subacromial steroid injections or both the EMTP and the steroid injections. The interventions and clinic follow-ups were over an 18-week period. A final postal questionnaire was sent out at one year. The progress of the patients was monitored using the Oxford Shoulder Score (OSS) and the SF36 general health questionnaire.

Seventy-nine GPs referred 186 patients, of whom 112 were randomised (Control=27, EMTP=29, Injections=28, Both=28). 64 patients were female and 48 male. The mean age was 54.5 years (range 23-88 years). Ninety patients completed the trial (Control=20, EMTP=22, Injections=26, Both=22). Sixty-two returned the follow-up questionnaire.

By paired sample t-tests, no significant differences were found between the OSS scores or SF-36 (physical health total) at the beginning and end of the intervention period, or at one year, in any group. There were no differences in changes in scores between groups. Two patients in the injection group went on to surgery, along with one each in the control and EMTP groups.

We have found no significant differences in outcome between steroid injections, a physiotherapy package, both treatments, or symptomatic treatment in our group of patients presenting with symptoms of painful arc of the shoulder.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_7 | Pages 7 - 7
1 May 2015
Berstock J Blom A Beswick A
Full Access

The subvastus approach has potential early advantages over the medial parapatellar approach because it avoids disruption of the quadriceps tendon. We present a systematic review and meta-analysis of the functional outcomes and complications associated with these two approaches.

Following an extensive search of prospective trials published in any language before 1st August 2014, studies were screened in duplicate according to pre-defined inclusion and exclusion criteria. Sixteen randomised controlled trials were included in the meta-analysis comprising of 1,711 total knee replacements.

Knee society score and range of movement were significantly superior in the subvastus group at early and one-year follow up. The subvastus approach was also associated with a statistically significant reduction in the requirement for intraoperative lateral release, perioperative blood loss, visual analogue score for pain on day 1 post operatively, and the number of days to achieve active straight leg raising. Both tourniquet time and total operative time were increased for the subvastus approach. There was no statistically significant difference in complications such as stiffness requiring MUA, superficial and deep infection and deep vein thrombosis.

The subvastus approach confers a functional advantage over the medial parapatellar approach to the knee which lasts for a minimum of one year postoperatively.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 43 - 43
1 Jan 2012
Kerr D Blair A
Full Access

Background

Exercise can be effective in treating Chronic Low Back Pain (CLBP) (Hayden et al 2005). Pilates-based group exercise programmes may be useful in the treatment of CLBP.

Aim

To carry out a feasibility study of group Pilates exercise course compared to individual physiotherapeutic intervention and a waiting list control, in the treatment of CLBP.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_I | Pages 14 - 14
1 Jan 2004
Gasparini G Tafuro L Cerciello S Pola E De Santis E
Full Access

Aseptic loosening is one of the most frequent cause of total knee arthroplasty (TKA) failure; it is related to a fatigue-type wear which can rapidly break up a tibial polyethylene (PE) inlay. PE debris production is the result of this wear and depend on contact stress between the components. This crucial parameter is more related to conformity than to load tranfer. That is why mobile bearing TKA seems to represent a valid solution to the PE debris production. In fact this implant offers great tibio-femoral conformity without an increased risk of loosening due to increased axial torque. Mobile bearing TKA also eneables the surgeon to self correct tibial component malrotation. On the other hand this implant could lead to new problems such as bearing dislocation or breakage and a possible new wear pattern at the PE-tibial metal tray interface.

We performed 100 consecutive cemented posterior stabilised TKA using randomly in 50 cases a mobile bearing and in 50 cases the same implant with a fixed bearing. The mean follow up was 15 months. The results in mobile bearing group are the following. Hospital for Special Surgery (HSS) score improved from 38 to 91 after the surgery. Preoperative Range of Movement (ROM) was 71 while the post op value was 107. No lucencies > 1 mm were observed. There were no statistically significant differences among the mobile bearing group and the fixed bearing one. Despite our short follow up, this implant offers the same good clinical results if compared to other devices, and allows the surgeons to correct errors in positioning the implant.

In future we have to consider that this possibility will lead to an abnormal load stresses distribution and to a higher risk of late loosening.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 593 - 593
1 Nov 2011
Goldstein C Petrisor B Drew B Bhandari M
Full Access

Purpose: A significant proportion of spine fusion operations may result in a non-union. Electromagnetic stimulation is a non-invasive method used to promote spine fusion although the efficacy of its use in this regard remains uncertain. The purpose of this systematic review and meta-analysis is to evaluate the effect of electromagnetic stimulation on spine fusion.

Method: Five electronic databases (MEDLINE, Embase, CINAHL, PubMed and the Cochrane Central Register of Controlled Trials) were searched from database inception to July 2009 for randomized controlled trials of electrical stimulation and spinal fusion. In addition, we performed a hand search of four relevant journals from January 2000 to July 2009, the on-line proceedings of the North American Spine Society Annual Meeting from 2002 to 2008 and bibliographies of eligible trials. Trials randomizing adult patients undergoing any type of spine fusion to active treatment with direct current, capacitance coupled or pulsed electromagnetic field stimulation or placebo and reporting on fusion rates were included. Two independent reviewers extracted data regarding clinical outcomes, stimulation device, treatment regimen and methodologic quality.

Results: Of 1650 studies identified seven met the inclusion criteria. Electromagnetic stimulation in lumbar spine fusion was evaluated in five studies and two addressed cervical spine fusions. The use of electromagnetic stimulation in lumbar spine fusion resulted in a significant decrease in the risk of non-union (relative risk 0.60, 95% confidence interval 0.38 to 0.93, p = 0.02, I2 = 57%). The observed reduction in risk of nonunion with electromagnetic stimulation was not affected by smoking or the number of levels fused. Due to limited and conflicting trials, similar effects were not observed in the two studies evaluating cervical spine fusion rates (relative risk 0.85, 95% confidence interval 0.29 to 2.53, p = 0.77, I2 = 56%).

Conclusion: Pooled analysis shows a 40% reduction in the risk of non-union of lumbar spine fusions with the use of electromagnetic stimulation although a similar effect was not observed for fusions of the cervical spine. However, due to study heterogeneity the current indications for the use of electrical stimulation in spine fusion remain somewhat unclear.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 561 - 561
1 Nov 2011
Simunovic N Bhandari M Kooistra BW Dijkman B
Full Access

Purpose: Estimating recruitment for clinical trials is vital to ensuring the feasibility of larger multi-centre trials. We compared estimates of potential recruitment from a prospective eight-week screening study and a retrospective chart review across sites participating in three fracture management trials.

Method: During the planning phase of two multi-centre, randomized controlled trials regarding the operative treatment of hip (two studies) and tibial shaft (one study) fractures, 74 clinical sites provided estimates of the annual recruitment rate both retrospectively (based on chart reviews) and prospectively. The prospective estimate was generated by screening all incoming patients for eligibility in the concerning trial, without actually enrolling any patient, for eight weeks. These prospective and retrospective estimates were correlated with each other (for 74 sites) and with actual one-year recruitment rates in the definitive trial (for nine sites).

Results: On average, a centre’s prospective estimate was only slightly lower than its retrospective estimate (3.1 patient-difference, p=0.64). Both predictions were substantial overestimations of recruitment in the definitive trial; only 31% (95% confidence interval: 28%–35%) of retrospectively estimated patients and 34% (95% confidence interval: 30%–37%) of prospectively estimated patients were recruited in the definitive trials (p< 0.001 and p=0.001 for both overestimations, respectively). The overall costs of conducting retrospective chart reviews and prospective screening studies in 65 sites were $68,107 ($CAN) and $153,725 ($CAN), respectively.

Conclusion: Compared to relatively simple and inexpensive chart reviews, prospectively screening for eligible patients at clinical sites did not result in more accurate predictions of accrual in large randomized controlled trials.


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_I | Pages 26 - 26
1 Jan 2003
Wildin CJ Bhowal B Dias JJ
Full Access

The benefits and risks of early fixation of scaphoid fractures were investigated in 88 patients in the working age group with clear bicortical fractures. Patients were randomised using a random number sheet into 44 who had early internal fixation using a Herbert Screw without a cast and 44 who were treated conservatively in a Colles’ type plaster cast for eight weeks. Patients were reviewed at 2,8,12,26 and 52 weeks with pain severity, tenderness, swelling, wrist movement, grip strength, the Patient Evaluation Measure (PEM) outcome score and x-rays assessed at each visit.

There was no difference between groups for age, sex, nature of injury, dominance, side injured or type of scaphoid fracture. The two groups were similar for pain severity at each of the intervals. Eight of the conservative group and one fracture in the operated group did not unite (p=0.01).

At the 8th and 12th week visits the operated group was better than those treated in a cast for wrist range, grip strength and PEM score (less is better). Thereafter there was no difference between groups.

Patients operated on returned to work at a mean of 6 weeks after their injury compared to 11 weeks for those treated conservatively. There were no serious complications, 6 patients had hypertrophic or itchy scars and one had hypoaesthesia in the palmar cutaneous branch of the median nerve distribution.

Early fixation of scaphoid fractures can be offered as an alternative to cast immobilisation with good early benefits and low risk, however the surgery can be technically difficult.