Vermesan 2013.
Study characteristics | ||
Methods |
Study design: single centre, parallel‐group, two‐arm, randomised controlled trial Setting: hospital in Italy Trial time period: not reported Interventions: arthroscopic surgery versus a single intra‐articular glucocorticoid injection Sample size calculations: not reported Analysis: not reported |
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Participants |
Number of participants
Inclusion criteria
Exclusion criteria: not reported Baseline characteristics Arthroscopic surgery
Glucocorticoid injection
Pre‐treatment group differences: there were no differences in the baseline characteristics between the two groups. |
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Interventions |
Arthroscopic surgery Arthroscopic debridement. No description of this procedure was provided. Intra‐articular glucocorticoid injection A single intra‐articular glucocorticoid injection (1 mL of betamethasone in 4 mL of 1% lidocaine) was administered. |
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Outcomes | Outcome was measured at 1 month and 1 year of follow‐up. Oxford Knee Scores which range from: 0 to 19 = severe knee arthritis; 20 to 29 = moderate to severe arthritis; 30 to 39 = mild to moderate arthritis; 40 to 48 = satisfactory joint function (Dawson 1998) Outcomes used in this review at 1 month and 1 year
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Notes |
Funding: no information on the funding source was provided Trial registration: not done Adverse events: only knee‐related adverse events reports (total of 5 participants had knee replacement); unclear if trial measured other adverse events Knee surgery (replacement or osteotomy): a total of 5 participants (4.2%) in both groups had a knee replacement. Per‐group data not given. Progression of knee OA: not reported Withdrawals: 12/60 in the glucocorticoid injection group and 10/60 in the arthroscopic group |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of sequence generation process provided |
Allocation concealment (selection bias) | Unclear risk | There was no information on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and study personnel was not reported. Probably not done |
Blinding of outcome assessor Self‐reported outcomes | High risk | As blinding of participants was not reported and probably was not done, there is likely to be a risk of bias in the measurement of knee pain and function using the Oxford Knee Score. |
Blinding of outcome assessor Assessor‐reported outcome (knee replacement) | Low risk | No assessor‐reported outcomes were measured in this trial. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There was no loss to follow‐up for the 1 month follow‐up. 12/60 (20%) participants in the glucocorticoid injection group and 10/60 (16%) participants in the arthroscopic group did not have outcome data at the 12 month follow‐up. The reasons for loss to follow‐up were not reported. |
Selective reporting (reporting bias) | High risk | Trial registration not done and protocol not available. The published article had results for one study outcome ‐ the Oxford Knee Scores. Correlation analysis was reported in the methods but this was not reported in the results |
Other bias | Low risk | No other bias apparent |