Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

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 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). CONCLUSION: 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

Platelet-Rich Plasma Injections for the Treatment of Ankle Osteoarthritis

Background: Ankle osteoarthritis is debilitating and usually affects relatively young people, often as a result of previous ankle traumas, frequently occurring in sports. Platelet-rich plasma (PRP) injections for ankle osteoarthritis have shown no evidence of benefit over the course of 26 weeks. Previous studies on PRP for knee osteoarthritis showed that clinically significant improvements with PRP occurred between 6 to 12 months in the absence of initial benefit. No studies have evaluated the effect of PRP from 6 to 12 months in ankle osteoarthritis. Purpose: To assess the efficacy of PRP injections in ankle osteoarthritis over the course of 52 weeks. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In this 52-week follow-up trial, 100 patients with ankle osteoarthritis were randomized to a PRP group or placebo (saline) group. Patients received 2 intra-articular talocrural injections: at inclusion and after 6 weeks. Patient-reported outcome measures were used to assess pain, function, quality of life, and indirect costs over 52 weeks. Results: Two patients (2%) were lost to follow-up. The adjusted between-group difference for the patient-reported American Orthopaedic Foot &amp; Ankle Society score over 52 weeks was −2 points (95% CI, −5 to 2; P =.31) in favor of the placebo group. No significant between-group differences were observed for any of the secondary outcome measures. Conclusion: For patients with ankle osteoarthritis, PRP injections did not improve ankle symptoms and function over 52 weeks compared with placebo injections. Registration: NTR7261 (Netherlands Trial Register).</p

Platelet-Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): protocol of a Dutch multicentre, stratified, block-randomised, double-blind, placebo-controlled trial

INTRODUCTION: Platelet-rich plasma (PRP) is a potentially efficacious treatment for ankle osteoarthritis (OA), but its use has not been examined in high-quality studies. Systematic reviews show that PRP injections significantly decrease pain and improve function in patients with knee OA. Ankle OA is more common than hip or knee OA in the young active population; with a prevalence of 3.4%.PRP injections in ankle OA are shown to be safe and improve quality of life over time, but no randomised controlled trial has been conducted. Our randomised controlled trial will evaluate the efficacy of PRP injections for symptom reduction and functional improvement, compared with placebo, in the treatment of ankle (talocrural) OA. METHODS AND ANALYSIS: We will conduct the Platelet-Rich plasma Injection Management for Ankle OA study: a multicentre, randomised, placebo-controlled trial. One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection. Both groups will receive two injections of PRP or placebo at an interval of 6 weeks. Primary outcome is the American Orthopaedic Foot and Ankle Society score at 26 weeks. Secondary outcomes determined at several follow-up moments up to 5 years, include Ankle Osteoarthritis Score, Foot and Ankle Outcome Score, pain

Pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus: double-blind randomized controlled multicenter trial

Background. Osteochondral talar defects usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracturing. Although this is mostly successful, early sport resumption is difficult to achieve, and it can take up to one year to obtain clinical improvement. Pulsed electromagnetic fields (PEMFs) may be effective for talar defects after arthroscopic treatment by promoting tissue healing, suppressing inflammation, and relieving pain. We hypothesize that PEMF-treatment compared to sham-treatment after arthroscopy will lead to earlier resumption of sports, and aim at 25% increase in patients that resume sports. Methods/Design. A prospective, double-blind, randomized, placebo-controlled trial (RCT) will be conducted in five centers throughout the Netherlands and Belgium. 68 patients will be randomized to either active PEMF-treatment or sham-treatment for 60 days, four hours daily. They will be followed-up for one year. The combined primary outcome measures are (a) the percentage of patients that resume and maintain sports, and (b) the time to resumption of sports, defined by the Ankle Activity Score. Secondary outcome measures include resumption of work, subjective and objective scoring systems (American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale, Foot Ankle Outcome Score, Numeric Rating Scales of pain and satisfaction, EuroQol-5D), and computed tomography. Time to resumption of sports will be analyzed using Kaplan-Meier curves and log-rank tests. Discussion. This trial will provide level-1 evidence on the effectiveness of PEMFs in the management of osteochondral ankle lesions after arthroscopy. Trial registration. Netherlands Trial Register (NTR1636)

Ankle instability

The ankle joint is the most congruent joint of the human body. Stability is provided by the bony configuration of the ankle mortise and the talar dome and by the ankle ligaments. During ankle motions, rotation and translation around and along the movement axes occur. Soft tissue stability is provided mainly by the ligaments. This article discusses ankle instability, injuries, and reconstructio

Treatment of a large intraosseous talar ganglion by means of hindfoot endoscopy

We report on 2 patients with a large intraosseous ganglion of the talus who were treated by means of a 2-portal endoscopic approach of the hindfoot with the patient in the prone position. By means of this approach, it is possible to visualize, debride, and graft a large intraosseous talar lesion. In both patients, the lesions were treated successfully, with no recurrence at follow u

Ankle Ligament Injuries

This chapter presents a clinical scenario of a 23-year-old male athlete who had suffered an inversion injury during a cutting movement while trying to pass an opponent. It also focuses on lateral ankle sprains (LAS). Many patients who present to the Emergency Department after sustaining an LAS mainly suffer from pain and are unable to bear weight on the affected ankle. Patients that present to the Emergency Department are often unable to bear weight on their affected ankle. To provide some stability, immobilization by means of a cast may be chosen as an acute treatment method. In patients that suffer from a severe lateral ligament injury, only elite athletes generally qualify for surgical treatment to enable quick recovery. The chapter then provides recommendations for implementing evidence-based practice in the clinical setting

Sports activity level after surgical treatment for chronic anterolateral ankle instability - A multicenter study

The objective of this retrospective multicenter study was to determine whether anatomic reconstruction or tenodesis produces better results in athletic patients with lateral ankle instability. Forty-one patients who underwent anatomic reconstruction and 36 patients who underwent tenodesis were followed up. The median preinjury Tegner score for both groups was 9 (range, 7 to 10). At follow-up, 2 to 10 years after surgical treatment, the median Tegner score for both groups was 8 (range, 4 to 10). In the tenodesis group, 17 patients had a lower Tegner score than before the operation, but in the anatomic reconstruction group only 4 patients had lower scores. Significantly more patients in the tenodesis group (15) had limited ankle dorsiflexion than in the anatomic reconstruction group (3). Plain radiographs revealed that 11 patients in the tenodesis group had medially located osteophytes, compared with only 2 patients in the anatomic reconstruction group. Stress radiographs revealed that more patients in the anatomic reconstruction group had normal laxity values than in the tenodesis group (38 and 28, respectively). According to the rating system developed by Good et al., 36 patients in the anatomic reconstruction group had a good or excellent result, versus 21 patients in the tenodesis group. Anatomic reconstruction was found to be superior to tenodesis in all of the investigated outcome measure

Interventions for treating chronic ankle instability

Chronic lateral ankle instability occurs in 10% to 20% of people after an acute ankle sprain. Initial treatment is conservative but if this fails and ligament laxity is present, surgical intervention is considered. To compare different treatments, conservative or surgical, for chronic lateral ankle instability. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL and reference lists of articles, all to February 2010. All identified randomised and quasi-randomised controlled trials of interventions for chronic lateral ankle instability were included. Two review authors independently assessed risk of bias and extracted data from each study. Where appropriate, results of comparable studies were pooled. Ten randomised controlled trials were included. Limitations in the design, conduct and reporting of these trials resulted in unclear or high risk of bias assessments relating to allocation concealment, assessor blinding, incomplete and selective outcome reporting. Only limited pooling of the data was possible.Neuromuscular training was the basis of conservative treatment evaluated in four trials. Neuromuscular training compared with no training resulted in better ankle function scores at the end of four weeks training (Ankle Joint Functional Assessment Tool (AJFAT): mean difference (MD) 3.00, 95% CI 0.3 to 5.70; 1 trial, 19 participants; Foot and Ankle Disability Index (FADI) data: MD 8.83, 95% CI 4.46 to 13.20; 2 trials, 56 participants). The fourth trial (19 participants) found no significant difference in the functional outcome after six weeks training programme on a cyclo-ergometer with a bi-directional compared with a traditional uni-directional pedal. Longer-term follow-up data were not available for these four trials.Four studies compared surgical procedures for chronic ankle instability. One trial (40 participants) found more nerve injuries after tenodesis than anatomical reconstruction (risk ratio (RR) 5.50, 95% CI 1.39 to 21.71). One trial (99 participants) comparing dynamic versus static tenodesis excluded 17 patients allocated dynamic tenodesis because their tendons were too thin. The same trial found that dynamic tenodesis resulted in higher numbers of people with unsatisfactory function (RR 8.62, 95% CI 1.97 to 37.77, 82 participants). One trial comparing techniques of lateral ankle ligament reconstruction (60 participants) found that operating time was shorter using the reinsertion technique than the imbrication method (MD -9.00 minutes, 95% CI -13.48 to -4.52). Two trials (70 participants) compared functional mobilisation with immobilisation after surgery. These found early mobilisation led to earlier return to work (MD -2.00 weeks, 95% CI -3.06 to -0.94; 1 trial) and to sports (MD -3.00 weeks, 95% CI -4.49 to -1.51; 1 trial). Neuromuscular training alone appears effective in the short term but whether this advantage would persist on longer-term follow-up is not known. While there is insufficient evidence to support any one surgical intervention over another surgical intervention for chronic ankle instability, it is likely that there are limitations to the use of dynamic tenodesis. After surgical reconstruction, early functional rehabilitation appears to be superior to six weeks immobilisation in restoring early functio