Background: While surgical trials can rarely blind surgeons or patients, they can often blind outcome assessors. The aim of this systematic review was threefold:

1) to examine the reporting of outcome measures in orthopaedic trials,

Specifically, we focused on an association between blinding of outcome assessment and the size of the reported treatment effect; in other words: does blinding of outcome assessors matter?

Methods: We reviewed 32 identified RCTs published in the Journal of Bone and Joint Surgery (American Volume), in 2003 and 2004 for the appropriate use of outcome measures. These RCTs represented 3.4% (32/938) of all studies published during that time period. All RCTs were reviewed by two of us for:

1) the outcome measures used and

We calculated the magnitude of treatment effect of blinded compared to un-blinded outcome assessors.

Results: The methodological validation and clinical usefulness of the clinician-based, patient-based, and generic outcome instruments varied. Ten of the 32 RCTs (31%) used a modified outcome instrument. Of these 10 trials, 4 (40%) failed to describe how the outcome instrument was modified. Nine (90%) of the 10 articles did not describe how their modified instrument was validated and retested. Sixteen (50%) of the 32 RCTs did not report blinding of outcome assessors where blinding would have been possible. Among those studies with continuous outcome measure, unblinded outcomes assessment was associated with significantly larger treatment effects (standardized mean difference 0.76 versus 0.25, p=0.01). Similarly, in those studies with dichotomous outcomes, unblinded outcomes assessments were associated with significantly greater treatment effects (Odds ratio 0.13 versus 0.42, unblinded versus blinded, p< 0.001). The ratio of odds ratios (unblinded to blinded) was 0.31 suggesting that unblinded outcomes assessment was associated with an exaggeration of the benefit of a treatment’s effectiveness in our cohort of studies.

Conclusion: Reported outcomes in RCTs are often modified and rarely validated. Half of the RCTs did not blind outcome assessors even though blinding of outcome assessors would have been feasible in each case. Treatment effects may be exaggerated if outcome assessors are unblinded. Emphasis should be placed on detailed reporting of outcome measures to facilitate generalization. Outcome assessors should be blinded where possible to prevent bias.

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

One should address methodological safeguards individually.

Our aim in this prospective study was to determine the best diagnostic method for discriminating between patients with and without osteochondral lesions of the talus, with special relevance to the value of MRI compared with the new technique of multidetector helical CT. We compared the diagnostic value of history, physical examination and standard radiography, a 4 cm heel-rise view, helical CT, MRI, and diagnostic arthroscopy for simultaneous detection or exclusion of osteochondral lesions of the talus. A consecutive series of 103 patients (104 ankles) with chronic ankle pain was included in this study. Of these, 29 with 35 osteochondral lesions were identified. Twenty-seven lesions were located in the talus.

Our findings showed that helical CT, MRI and diagnostic arthroscopy were significantly better than history, physical examination and standard radiography for detecting or excluding an osteochondral lesion. Also, MRI and diagnostic arthroscopy performed better than a mortise view with a 4 cm heel-rise. We did not find a statistically significant difference between helical CT and MRI. Diagnostic arthroscopy did not perform better than helical CT and MRI for detecting or excluding an osteochondral lesion.

Consecutive patients with a confirmed rupture of at least one of the lateral ligaments of the ankle were randomly assigned to receive either operative or functional treatment. They were evaluated at a median of 8 years (6 to 11).

In total, 370 patients were included. Follow-up was available for 317 (86%). Fewer patients allocated to operative treatment reported residual pain compared with those who had been allocated to functional treatment (16% versus 25%, RR 0.64, CI 041 to 1.0). Fewer surgically-treated patients reported symptoms of giving way (20% versus 32%, RR 0.62, CI 0.42 to 0.92) and recurrent sprains (22% versus 34%, RR 0.66, CI 0.45 to 0.94). The anterior drawer test was less frequently positive in surgically-treated patients (30% versus 54%, RR 0.54, CI 0.41 to 0.72). The median Povacz score was significantly higher in the operative group (26 versus 22, p < 0.001).

Compared with functional treatment, operative treatment gives a better long-term outcome in terms of residual pain, recurrent sprains and stability.

In this retrospective study, we assessed the outcome in 99 patients who underwent reconstruction of the lateral ligaments of the ankle for chronic anterolateral instability with a minimum follow-up of 15 years.

Two techniques were compared: 54 patients had an anatomical reconstruction (AR group) and 45 had an Evans tenodesis (ET group). They were followed up for 19.9 ± 3.6 years and 21.8 ± 4.6 years, respectively. During follow-up, seven patients in the AR group and 17 in the ET group required a further operation (p = 0.004). At follow-up, significantly more patients (n = 15) in the ET group had limited dorsiflexion than in the AR group (n = 6, p = 0.007) and 18 in the ET group had a positive anterior drawer test compared with seven in the AR group (p = 0002). In the ET group 27 had tenderness on palpation of the ankle compared with 15 in the AR group (p = 0.001). Stress radiographs showed ligamentous laxity significantly more often in the ET group (n = 30) than in the AR group (n = 13, p < 0.001). The mean values for talar tilt and anterior talar translation were significantly higher in the ET group than in the AR group (p < 0.001, p = 0.007, respectively). There were degenerative changes on standard radiographs in 32 patients in the AR group and 35 in the ET group (p = 0.05). Four patients in the ET group had developed severe osteoarthritis compared with none in the AR group (p = 0.025). Assessment of functional stability revealed a mean Karlsson score of 83.7 ± 10.4 points in the AR group and 67.0 ± 15.8 points in the ET group (p < 0.001). According to the Good rating system, 43 patients in the AR group had good or excellent results compared with 15 in the ET group (p < 0.001).

Compared with anatomical reconstruction, the Evans tenodesis does not prevent laxity in a large number of patients. Long-standing ligamentous laxity leads to degenerative change in the ankle, resulting in chronic pain, limited dorsiflexion and further operations. The functional result deteriorates more rapidly after the Evans tenodesis than after anatomical reconstruction.