Methods |
Treatment allocation by alternating Independent & blinded assessment Minimum follow‐up: 24 months Loss to follow‐up: None Graft re‐ruptures: not reported |
Participants |
Italy 120 patients with chronic (> 30 days), isolated unilateral ACL tears PT: n = 60, mean 25 years (16 to 39 years), 46 males / 14 females HT: n = 60, mean 25 years (15 to 39 yrs), 46 males / 14 females |
Interventions |
Arthroscopically assisted ACL reconstruction with: 1. Patellar tendon (single incision; proximal fixation ‐ Tunneloc screw; tibial fixation ‐ Soft threaded interference screw) versus 2. Hamstring tendon: Semitendinosus/gracilis tendons (4 strands; single incision; proximal fixation ‐ Bone Mulch screw; tibial fixation ‐ WasherLoc device) |
Outcomes |
Minimum 4, 12 and 24 months follow‐up for: Static stability with KT‐1000 (134N & MM); Lachman (defined by the IKDC 2000); pivot shift (defined by IKDC 2000); IKDC (2000); return to sports/activity; strength with Cybex (60, 120, 180 deg/sec); KOOS; range of motion; anterior knee pain |
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 |
Alternating. |
Allocation concealment (selection bias) |
High risk |
|
Blinding (performance bias and detection bias) All outcomes |
Low risk |
Independent blinded assessor for follow‐up outcome assessment. Patients were not blinded. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
|
Selective reporting (reporting bias) |
High risk |
Did not report re‐ruptures, contralateral ruptures or withdrawals. |
Other bias |
High risk |
It is difficult to understand how 60 patients randomly assigned to each group resulted in identical numbers of left and right sided injured knees, the same sex distribution and mean age. There were no patients lost to follow‐up despite an a priori sample size estimate, which allowed for a 20% lost to follow‐up. In their previous published trial, only 3 of 60 patients were lost to follow‐up, which suggests that accounting for a 20% lost to follow‐up rate in the sample size estimate was excessive. |