Erdmann 1994.
Methods | Single centre RCT (a cadaveric study and a pilot study preceded) | |
Participants | 71 participants with 105 hands were recruited (53 ECTR, 52 OCTR) ECTR group: mean age 52.7 years, male:female ratio 1:3.7 OCTR group: mean age 54.1 years, male:female ratio 1:2 The participants were divided into 2 main groups. Group A comprised 25 participants (50 hands) with bilateral symptoms who underwent simultaneous surgery, with the dominant hand randomised to one technique, and the other hand undergoing the alternative procedure. Group B comprised 46 participants (55 hands) with unilateral symptoms who were randomised per hand exclusively to either ECTR or OCTR |
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Interventions | 2‐portal ECTR (extrabursal) vs OCTR | |
Outcomes | Follow‐up at 1 and 2 weeks, 1, 3 and 6 months and 1 year Grip and pinch strength, and carpal tunnel pain Time to relief of symptoms and return to work or activities of daily living Electroneurophysiological tests at 3 months |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information given not adequate. "Randomization was performed using a sealed envelope system" |
Allocation concealment (selection bias) | Unclear risk | Information given not adequate. "Randomization was performed using a sealed envelope system". (For group A participants (bilateral symptoms), no allocation concealment was evident for the contralateral hand) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No information given. Participants and personnel could not be blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No information given. Participants and personnel could not be blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information given regarding any missing data |
Selective reporting (reporting bias) | Unclear risk | Only diagrams were used. No absolute numbers were given and no SDs. However, the authors gave information regarding the statistical significance of the comparisons |
Other bias | High risk | The dominant hand was operated via ECTR in 67% of participants and via OCTR in 41% No information given regarding conflicts of interest or industry support |