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

Ejerhed 2003

Methods Sealed envelopes, but randomization method not described Independent, but non blinded assessment Minimum follow‐up: 24 months Loss to follow‐up: 1 PT and 1 HT (excluded from analysis) Graft re‐ruptures: 1 PT and 2 HT (excluded from analysis)
Participants Sweden 71 participants with chronic (> 2 months), unilateral ACL tears PT: n = 34, mean 26 years (14 to 49 years), 21 males / 11 females HT: n = 37, mean 29 years (15 to 59 years), 25 males / 9 females
Interventions Arthroscopic ACL reconstruction with: 1. Patellar tendon (2 incisions; proximal fixation ‐ "Silk" interference screw (7 mm); tibial fixation ‐ "Silk" interference screw (9 mm)) versus 2. Hamstring tendon: semitendinosus tendon (3 or 4 strands; single incision; proximal and tibial fixation ‐ soft‐threaded RCI interference screw (7 mm))
Outcomes Minimum 24 months follow‐up for: Lachman (0/1+2+3+); Lysholm; Tegner; range of motion; static stability with KT‐1000 (89N); single leg hop test; IKDC; anterior knee pain; knee walking test; strength with Cybex (60 deg/s)
Notes Additional information received from Ejerhed comprised individual pre‐ and post‐operative patient data for the following outcomes: anterior knee pain, knee walking, kneeling, Lysholm, Cybex extension and flexion of injured and non‐injured sides, KT‐1000, range of motion (extension & flexion), IKDC, Tegner activity level.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details
Allocation concealment (selection bias) Unclear risk Sealed envelopes but allocation process to preserve concealment was not described.
Blinding (performance bias and detection bias) All outcomes High risk Independent assessor.
Incomplete outcome data (attrition bias) All outcomes Low risk
Selective reporting (reporting bias) High risk Excluded re‐ruptures in final analysis. Did not report contra‐lateral ruptures or withdrawals.
Other bias High risk Lack of explicit inclusion and exclusion criteria, patient sampling strategy and 14 patient overlap with Laxdal's trial.