Methods | Treatment allocation by birth month Independent, non blinded assessment Follow‐up: mean 42 months (24 to 60 months) [1996 publication]; mean 102 months (72 to 121 months) [2001 publication] Loss to follow‐up: 1 PT (2 incision), 1 HT (2 patients in total; excluded from analysis) Graft re‐ruptures (traumatic): 2 PT (1 incision), 2 HT (4 patients in total; included in analysis) | |
Participants | USA 127 participants (1996 publication) / 229 participants (2001 publication) with acute (< 3 weeks) or chronic (> 3 weeks), isolated unilateral ACL tears Group allocation data for 125 participants (1996 publication) / 225 participants (2001 publication) PT (1 incision): n = 45, mean 28 years (14 to 56 years), 28 males / 17 females (1996 publication); n = 75 (2001 publication) PT (2 incision): n = 40, mean 26 years (15 to 49 years), 26 males / 14 females (1996 publication); n = 75 (2001 publication) HT: n = 40, mean 27 years (14 to 56 years), 27 males / 13 females (1996 publication); n = 75 (2001 publication) Loss to follow‐up: 1 PT (1 incision) and 1 PT (2 incision) and 2 deaths (group assignment not reported). Failures (traumatic, included in the analysis) : 2 PT (2 incision) and 2 HT (1996 publication) / 5 PT (1 incision), 4 PT (2 incision) and 1 HT(2001 publication). |
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Interventions | Arthroscopically‐assisted ACL reconstruction with: 1. Patellar tendon: 1 or 2 incisions, (proximal fixation ‐ interference screw (9 x 25 mm); tibial fixation ‐ interference screw, or barbed staples for long grafts (17 cases)) versus 2. Hamstring tendon: semitendinosus/gracilis tendons (2 strands; 2 incisions; proximal and tibial fixation ‐ barbed staples) | |
Outcomes | Mean 42 months follow‐up for: Lysholm, KT‐2000 (Maximum Manual), range of motion, Lachman (0/1/2/3); single‐leg hop, return to activity; failures; strength with Biodex, patellofemoral crepitus; IKDC; radiographs. Mean 102 months follow‐up for: KT‐2000 (Maximum Manual), return to activity; failures; strength with Biodex, patellofemoral crepitus; IKDC; radiographs. |
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Notes | No additional methodological information or individual patient data were received from the authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Allocation by birth month. |
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 | The two patients lost to follow‐up and two deaths were excluded from the analysis. |
Selective reporting (reporting bias) | High risk | The authors failed to report the following outcomes in their 2001 publication on the larger groups of patients: Return to activity; Lachman; range of motion; patellofemoral crepitus; Lysholm score and single leg hop. |
Other bias | High risk | Recruitment in this trial continued beyond the point where the results of the original publication (1996) were likely analysed. This may have resulted in a selection bias in the 2001 publication. |