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

Laxdal 2005

Methods Closed envelopes, but randomization method not described Independent, but non blinded assessment Mean follow‐up: 26 months (24 to 43 months) Loss to follow‐up: 9 patients in total (excluded from analysis) Exclusions from analysis (2 patients in total): 1 PT (contralateral rupture) + 1 HT(ST/G) (previous ACL reconstruction) Graft re‐ruptures after return to sport (excluded from analysis): 1 HT(ST/G); 1 HT(ST) and 1 PT. Failures due to sepsis (excluded from analysis): 1 HT(ST/G) and 1 HT(ST)
Participants Sweden 134 participants with chronic (> 2 months), isolated unilateral ACL tears Group allocation data for 118 participants. PT: n = 40, mean 28 years (16 to 52 years), 29 males / 11 females HT(ST): n = 39, mean 24 years (12 to 41 years), 22 males / 17 females HT(ST/G): n = 39, mean 26 years (15 to 35 years), 28 males / 11 females
Interventions Arthroscopically‐assisted ACL reconstruction with: 1. Patellar tendon (single incision, transtibial technique, proximal and tibial fixation ‐ Acufex interference screw) versus 2. Hamstring tendon: 3‐strand semitendinosus graft (ST) (single incision, soft‐threaded, round‐headed RCI interference screw (7 mm) ‐ tibial and femoral); or 4‐strand semitendinosus/gracilis graft (ST/G) (single incision, soft‐threaded, round‐headed RCI interference screw ‐ tibial and femoral)
Outcomes Mean 26 months follow‐up for: Tegner, Lysholm, KT‐1000 (89N), range of motion, single‐leg hop, knee walking test, anterior knee pain, IKDC, Cybex
Notes The original sample size was 50 per group, but recruitment ended early.
Additional information received for trial comprised individual pre‐ and post‐operative patient data for the following outcomes: KT‐1000, Lysholm, Tegner, single‐leg hop, IKDC, knee walk test, re‐rupture, patellofemoral pain, Lachman (0/1+/2+), pivot shift (1/2/3), range of motion (flexion and extension), Cybex flexion and extension strength
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details
Allocation concealment (selection bias) Unclear risk Closed envelopes, but allocation process to preserve concealment was not described.
Blinding (performance bias and detection bias) All outcomes High risk
Incomplete outcome data (attrition bias) All outcomes High risk Patients excluded from analysis due to lost to follow‐up, re‐ruptures and sepsis.
Selective reporting (reporting bias) Low risk
Other bias High risk Recruitment was curtailed at 134 patients due to "time factor". Original sample size was determined a priori to be 150 patients. There is an overlap of 14 patients that were also included in Ejerhed's trial.