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.

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

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

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

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

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

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

Aims

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

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

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

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

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

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

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

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

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

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.

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.