Sajovic 2006
Methods | Treatment allocation by operative registration position Non blinded, not independent assessment Minimum follow‐up: 60 months Loss to follow‐up: 2 PT and 1 HT (excluded from analysis) Exclusions from analysis (5 patients in total): 3 PT and 2 HT (due to contralateral ruptures) Graft re‐ruptures: 1 PT and 1 HT (revision surgery) | |
Participants | Slovenia 64 participants with acute or chronic isolated unilateral ACL tears PT: n = 32 randomized / n = 26 analyzed (4 acute, 22 chronic), mean 27 years (16 to 46 years), 14 males / 12 females HT: n = 32 randomized / n = 28 analyzed (4 acute, 24 chronic), mean 24 years (14 to 42 years), 13 males / 15 females | |
Interventions | Arthroscopically‐assisted ACL reconstruction with: 1. Patellar tendon (single incision; proximal fixation ‐ metal round‐head cannulated interference (RCI) screw; tibial fixation ‐ bioabsorbable interference screws) versus 2. Hamstring tendon: semitendinosus/gracilis tendons (4 strands; single incision; proximal fixation ‐ custon left‐threaded or right‐thread round‐head cannulated interference (RCI) screw; tibial fixation ‐ bioabsorbable interference screw) | |
Outcomes | Minimum 60 months follow‐up for: Lysholm, KT‐2000 (89 N and 134 N), range of motion, Lachman (A/B/C); pivot shift; single‐leg hop, anterior knee pain, IKDC, return to activity, radiographs | |
Notes | Additional information received from Sajovic comprised a description of the lack of a sample size calculation, and individual pre‐ and post‐operative patient data for the following outcomes: IKDC, Lysholm, anterior knee pain, patellofemoral crepitation, flexion and extension deficits, Lachman, pivot shift, KT‐2000, donor side morbidity, single‐leg hop, x‐ray arthrosis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Treatment allocation by operative registration position. |
Allocation concealment (selection bias) | High risk | |
Blinding (performance bias and detection bias) All outcomes | High risk | |
Incomplete outcome data (attrition bias) All outcomes | High risk | Patients were excluded due to graft re‐ruptures, contra‐lateral ruptures and lost to follow‐up. |
Selective reporting (reporting bias) | High risk | Baseline information was not provided for the patients excluded from the final analysis. |
Other bias | Unclear risk | Insufficient information was available to understand the eligible population and how patients were included and excluded from the trial. |