Eriksson 2001
Methods | Closed envelopes, but randomization method not described Independent, but non blinded assessment Mean follow‐up: 33 months (median 31 months) Loss to follow‐up: 4 patients in total (excluded from analysis) Graft re‐ruptures (all traumatic): 2 PT (no revision surgery), 3 HT (no revision surgery), 1 HT requiring revision surgery (total of 10 patients excluded from the analysis) | |
Participants | Sweden 164 participants with chronic (> 2 months), isolated unilateral ACL tears and an overall mean age of 25.7 years (+/‐6.9 years), PT: n = 84, mean 25 years (15 to 40 years), 41 males / 43 females HT: n = 80, mean 27 years (16 to 45 years), 55 males / 25 females | |
Interventions | Arthroscopic ACL reconstruction with: 1. Patellar tendon (single incision; proximal fixation ‐ non‐absorbable interference screw (7 x 20 mm); tibial fixation ‐ non‐absorbable interference screw (9 x 20 mm)) versus 2. Hamstring tendon: semitendinosus tendon (4 strands; single incision; proximal fixation ‐ Endobutton; tibial fixation ‐ screws) | |
Outcomes | Mean 33 months follow‐up for: Stryker laxity test (9.08 kg, 18.16 kg); range of motion; pivot shift; Lachman (as defined by the IKDC 1995); single‐leg hop; Tegner activity level; Lysholm; patellofemoral pain; IKDC; patient satisfaction; knee function (VAS) | |
Notes | Additional information received from Eriksson comprised a description of the allocation concealment methodology, lack of a sample size calculation, and the mean age for each group. Eriksson also provided individual patient data for the following outcomes: Tegner activity level, Lysholm, single leg hop, IKDC, ROM of index and contralateral knees, flexion and extension deficits, Stryker strength (20lbs) for index and contralateral knees; Lachman; anterior and posterior drawer tests; pivot shift test; MCL and LCL stability; patellofemoral, medial and lateral crepitus; harvest site pathology; thigh circumference of the index and contralateral legs; pain. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details |
Allocation concealment (selection bias) | Low risk | Closed envelopes opened within one hour of surgery. |
Blinding (performance bias and detection bias) All outcomes | High risk | Independent assessor. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The authors excluded patients who were lost to follow‐up and those who suffered a re‐rupture, of the ACL graft. |
Selective reporting (reporting bias) | Low risk | |
Other bias | High risk | Gender distribution was different between the two groups at baseline. |