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

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

The promotion and practice of evidence-based medicine necessitates a critical evaluation of medical literature including the “gold standard” of randomised clinical trials. Recent studies have examined the quality of randomised clinical trials in various surgical specialties, but no study has focused on pediatric orthopedics. The purpose of this study was to assess and describe the quality of randomised clinical trials published in the last ten years in journals with high clinical impact in pediatric orthopaedics.

All of the randomised clinical trials in pediatric orthopedics published in five well-recognised journals between 1995–2005 were reviewed using the Detsky Quality Assessment Scale.

The mean percentage score on the Detsky Scale was 53% (95% CI: 46%–60%). Only seven (19%) of the articles satisfied the threshold for a satisfactory level of methodologic quality (Detsky > 75%).

The majority of randomised clinical trials in pediatric orthopedics that are published in well-recognised, peer-reviewed journals demonstrate substantial deficiencies in methodologic quality. Particular areas of weakness include inadequate rigor and reporting of randomization methods, use of inappropriate or poorly-described outcome measures, inadequate description of inclusion and exclusion criteria and inappropriate statistical analysis. Further efforts are necessary to improve the conduct and reporting of clinical trials in this field in order to avoid inadvertent misinformation of the clinical community.

Purpose

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

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

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

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

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

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

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

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

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

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;

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.

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.

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.

Backgroud:

Periarticular multimodal drug injection (PMDI) during total knee arthroplasty (TKA) has been reported with promising effects, but some results still remain controversial. Therefore, we conducted a systematic review and meta-analysis based on randomized controlled trials (RCTs) to evaluate the efficiency and safety of PMDI technique in TKA.

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

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

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

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

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.

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.

To investigate the effectiveness of surgical fusion for chronic low back pain (CLBP) compared to non-surgical intervention, databases were searched from 1966-2005. The meta-analysis was based on the mean difference in Oswestry Disability Index (ODI) change from baseline to follow-up. Four studies were eligible (634 patients). The pooled mean difference in ODI was 4.13 in favour of surgery (95% CI: -0.82-9.08; p=0.10; I2=44.4%). Surgery was associated with a 16% pooled rate of complication (95% CI: 12-20%, I2=0%).

The cumulative evidence does not support surgical fusion for CLBP due to the marginal improvement in ODI which is of minimal clinical importance.

Background: Chronic low back pain is the most common complaint of the working age population. Controversy exists regarding the benefit of surgical fusion of the spine for the treatment of chronic low back pain. We performed a meta-analysis of randomised controlled trials to investigate the effectiveness of surgical fusion for chronic low back pain compared to non-surgical intervention.

Methods: Several electronic databases (MEDLINE, EMBASE, CINAHL, Science Citation Index and Cochrane registry of clinical trials) were searched from 1966 to October 2005. Two authors independently extracted data on study characteristics and methodological quality and the number of patients with early complications from surgery. The random-effect meta-analysis comparison was based on the mean difference in Oswestry Disability Index (ODI) change from baseline to follow-up of patients undergoing surgical versus non-surgical treatment. Between-study heterogeneity was analyzed by means of I2.

Results: Four studies of 58 articles identified in the search were eligible with a total of 740 patients. One of the studies recruited patients with adult isthmic spondy-lolisthesis, whereas the other studies recruited patients with a history of chronic low back pain of at least 1 year duration. Surgical treatment involved posterolateral fusion with or without instrumentation or flexible stabilisation. Non-surgical treatment involved exercise programs with or without cognitive therapy. The follow-up period ranged from 1 to 2 years. The pooled mean difference in ODI between the surgical and non-surgical groups was statistically in favour of surgery (mean difference of ODI: 3.90; 95% confidence interval: 0.17–7.62; p=0.04; I2=21.4%). Surgical treatment was associated with a 13% pooled rate of early complication (95% confidence interval: 6–20%, I2=66.9%).

Conclusion: Surgical fusion for chronic low back pain favoured an improvement in the ODI compared to non-surgical intervention. This difference in ODI is of minimal clinical importance. Furthermore, surgery was associated with a significant risk of complications. Therefore, the cumulative evidence at present does not support routine surgical fusion for the treatment of chronic low back pain.

Aim: A meta-analysis of randomised controlled trials was performed to investigate the effectiveness of surgical fusion for chronic low back pain compared to non-surgical intervention.

Methods: Several electronic databases (MEDLINE, EMBASE, CINAHL and Science Citation Index) were searched from 1966 to October 2005. Two authors independently extracted data. The meta-analysis comparison was based on mean difference in Oswestry disability index (ODI) change from baseline to follow up of patients undergoing surgical versus non-surgical treatment.

Results: Four studies of 58 articles identified in the search were eligible with a total of 740 patients. One of the studies recruited patients with adult isthmic spondylolisthesis, whereas the other studies recruited patients with a history of chronic low back pain of at least 1 year duration. Surgical treatment involved pos-terolateral fusion with or without instrumentation and flexible stabilisation. Non-surgical treatment involved exercise programs with or without cognitive therapy. The follow-up period ranged from 1 to 2 years. The mean overall difference in ODI between the surgical and non-surgical groups was statistically in favour of surgery (mean difference of ODI: 3.90; 95% confidence interval: 0.17–7.62; p=0.04; I²=21.4%). Surgical treatment was associated with a 13% pooled rate of early complications (95% confidence interval: 6–20%).

Conclusion: Surgical fusion for chronic low back pain favoured an improvement in the ODI compared to non-surgical intervention; this difference in ODI is of minimal clinical importance. Furthermore, surgery is associated with a significant risk of complications. Therefore, the cumulative evidence at present does not support routine surgical fusion for the treatment of chronic low back pain.

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.

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.

To analyse procedural details - specifically vertebral levels treated and injected polymethylmethacrylate (PMMA) volumes - of the publications by Buchbinder et al. ¹ and Kallmes et al. ² in the context of best available basic science.

Review

Two randomised controlled trials published by the New England Journal of Medicine (NEJM) in 2009 comparing vertebroplasty to sham procedures conclude vertebroplasty to be no more effective than injection of local anaesthetic. This finding contradicts previous publications showing clinical efficacy.

Neither investigation provides a breakdown of vertebral levels treated (original publication and supplementary material). Only one investigation provides information on fill volumes with average of 2.8 ml +/− 1.2 ml SD.

The available basic science indicates a minimum fill volume of 13-16% of the vertebral body volume to be necessary for a relevant biomechanical effect on restoration of vertebral strength, according to which only vertebrae of the upper to mid thoracic spine could reasonably have received a biomechanically effective fill with the declared average volume of 2.8 ml +/− 1.2 ml SD.

The available data of the NEJM publications strongly indicates that the treatment arm includes insufficiently treated patients. The technical information provided by the NEJM publications is insufficient to conclusively prove or disprove the clinical efficacy of vertebroplasty.

Introduction. There is an ever increasing demand for Randomised Controlled Trials (RCTs) in Trauma and Orthopaedic Surgery. Patient recruitment is often challenging. Among other factors, individual surgeon's preference is often quoted as a major obstacle. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution, but could not help in everyday running of a trial. We wanted to develop a new trial eligibility assessment tool using the Collective Equipoise Principle. Methods. We developed an online system that quantifies collective uncertainty among a group of surgeons for an individual clinical case in real time. This data was collected for patients in the UK Heel Fracture Trial (UK HeFT) as an independent research project. Both patients who agreed or not to take part in the trial were approached in six weeks follow up clinic to avoid interference with clinical course. For those who agreed, anonymous clinical data together with images (Xrays and CT) was published on a secure on line forum and registered surgeons were alerted via email and SMS. Surgeons submitted their opinion instantly via specially designed interactive voting scale. 80:20 ethical uncertainty distribution limit was applied using Subjective Logic to calculate an Uncertainty Index (UnIx) for every patient. This approach was evaluated as an eligibility assessment tool for RCTs. Results. 70 consecutive patients (77 calcaneal fractures) were assessed by a panel of 12 Consultant Trauma surgeons from hospitals acros the UK. All patients were eligible for the UK HeFT according to standard eligibility criteria approach. UnIx demonstrated reliable correlation with level of uncertainty and confidence about treatment choice expressed by surgeons. The panel was certain about treatment for 9 (13%) patients. The assesment results were available within 48 hours from a case submission to the panel. Discussion and Conclusion. UnIx is an effective and ethical eligibility assessment tool based on surgeon's opinion. It can be calculated for every patient in Randomised Controlled Trials. This protects patients when there is no controversy about treatment choice. UnIx can potentially increase patient recruitment by including more patients for eligibility assessment and more sceptical surgeons in clinical trials. Patient's perception that his/her condition was assessed by surgical panel may also be important

There are a number of patients in whom hip preservation surgery is not indicated as they have developed signs of early osteoarthritis, and nor can they have a hip replacement as they are too early in the disease process. The use of PRP in OA of the hip has not been studied systematically and this study concisely collates all the available data in the use of PRP in Hip OA. This systematic review and meta-analysis aimed to assess intra-articular platelet-rich plasma as a therapeutic intervention for hip osteoarthritis, including the duration of efficacy, influence of dose and composition of PRP, and the incidence of adverse effects. We performed literature searches on the MEDLINE, EMBASE, CINHAL, WEB OF SCIENCE, COCHRANE and SCOPUS databases, and PRSIMA guidelines were followed. Data was pooled using random effects meta-analysis. We assessed quality of the included studies using the Methodological Index for Non-Randomised Studies (MINORS) instrument, with an additional assessment for Randomised Controlled Trials with the Revised Cochrane risk-of-bias tool for randomized trials (RoB 2). Eight studies were included in the analysis, with data from a total of 331 patients. PRP significantly reduced pain compared to baseline at multiple timepoints, with the greatest effect at 1–2mo follow-up. PRP only significantly improved function at the 1–2mo follow-up. A significantly larger reduction in pain was achieved with a single injection or PRP compared to multiple injections, a total injected dose of PRP <15mL compared to ≥15mL or using a leukocyte-poor PRP preparation compared to leukocyte-rich PRP. There were no lasting adverse effects. Low and moderate quality evidence suggests that PRP reduces pain and improves function at endpoint compared to baseline. Moderate quality evidence suggests a larger reduction in pain is achieved with a single injection of PRP compared to multiple injections, and low quality evidence attributes a larger reduction of pain with a total injected dose of PRP <15mL compared to ≥15mL or using leukocyte-poor PRP compared to leukocyte-rich PRP

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding.

Cite this article: Bone Joint Res 2014;3:161–8.