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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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.