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 |
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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. |