Feller 2003
Methods | Computer‐generated random assignment Independent, but unblinded assessment Mean follow‐up: 36 months Loss to follow‐up: 4 PT and 2 HT (excluded from analysis) Withdrawals: 1 HT (excluded from analysis) Graft re‐ruptures (traumatic): 1 PT (excluded from analysis) | |
Participants | Australia 65 participants with acute (3 weeks to 12 months), isolated unilateral ACL tears PT: n = 31, mean 25.8 years (SD = 6 years), 23 males / 8 females HT: n=34, mean 26.3 years (SD = 6 years), 24 males / 10 females | |
Interventions | Arthroscopically‐assisted ACL reconstruction with: 1. Patellar tendon (single incision; proximal fixation ‐ EndoButton; tibial fixation ‐ Cannulated metallic interference silk screw) versus 2. Hamstring tendon: semitendinosus/gracilis tendons (4 strands; single incision; proximal fixation ‐ EndoButton; tibial fixation ‐ whip stitched suture and fixation post) | |
Outcomes | Minimum 36 months (also of 4, 8, 12 and 24 months) follow‐up for: Static stability with KT‐1000 (67N & 134N); range of motion; pivot shift; IKDC, Cincinnati; anterior knee pain (VAS); strength with Cybex II (60 & 240 deg/s); return to sport/activity; kneeling; radiographic assessment | |
Notes | Additional information received from Feller comprised individual pre‐ and post‐operative patient data for the following outcomes: IKDC, pain, effusion, pain with kneeling, flexion and extension deficits, heel height difference, KT‐1000 (67N, 134N, max manual), Cincinnati | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random assignment. |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding (performance bias and detection bias) All outcomes | High risk | |
Incomplete outcome data (attrition bias) All outcomes | High risk | Patients who were lost to follow‐up, withdrew or suffered a re‐rupture were excluded from the final analysis. |
Selective reporting (reporting bias) | Low risk | |
Other bias | Low risk |