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. |