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. 2011 Sep 7;2011(9):CD005960. doi: 10.1002/14651858.CD005960.pub2

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.