Aune 2001
| Methods | Randomization method: sealed envelopes Independent, non blinded assessment Minimum follow‐up: 24 months Loss to follow‐up: 8 patients in total (excluded from the analysis) Exclusions: 3 patients in total with ACL injury of the uninvolved knee (excluded from the analysis) Graft re‐ruptures: 1 PT and 2 HT had traumatic failures requiring revision sx (included in analysis) | |
| Participants | Norway 72 participants with subacute (as soon as inflammation was over and full range of motion was achieved) & chronic (failed non‐operative treatment) ACL deficiency PT: n = 35, mean 25 years, 19 males / 16 females HT: n = 37, mean 27 years, 21 males / 16 females | |
| Interventions | ACL reconstruction with: 1. Patellar tendon (single incision; proximal fixation ‐ Titanium interference screw (7 x 25 mm); tibial fixation ‐ interference screw (7 x 25 mm)) versus 2. Hamstring tendon: semitendinosus/gracilis tendons (4 strands; single incision; proximal fixation ‐ EndoButton and interference screw; tibial fixation ‐ barbed staples) | |
| Outcomes | Minimum 24 months (also 6 and 12 months) follow‐up for: Cincinnati score; static stability with KT‐1000 (mm); stairs hopple test; single leg hop; patient satisfaction; kneeling test; strength with Cybex 6000 (60 & 240 degrees/sec) | |
| Notes | Additional methodological information received from Aune comprised a description of allocation concealment and the sample size calculation. Individual patient data were unavailable. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details |
| Allocation concealment (selection bias) | Unclear risk | Sealed envelopes used for randomization, but allocation process to preserve concealment was not described. |
| Blinding (performance bias and detection bias) All outcomes | High risk | Independent assessor. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Eight patients were lost to follow‐up and three patients had contra‐lateral ruptures. The authors failed to report to which groups these patients belonged at baseline. |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | |