Zaffagnini 2006
| Methods | Treatment allocation by alternate systematic sampling Not independent, non blinded assessment Minimum follow‐up: 60 months Loss to follow‐up: none Exclusions from analysis: none Graft re‐ruptures: none | |
| Participants | Italy 50 participants with acute or chronic (1 to 13 months) isolated unilateral ACL tears PT: n = 25, mean 30.5 years (22 to 47 years), 16 males / 9 females HT: n = 25, mean 31.3 years (26 to 49 years), 15 males / 10 females HT and extra‐articular plasty: n = 25, mean 26.7 years (15 to 44 years), 18 males / 7 females | |
| Interventions | Arthroscopically‐assisted ACL reconstruction with: 1. Patellar tendon (single incision, proximal and tibial fixation ‐ interference screws) versus 2. Hamstring tendon: semitendinosus/gracilis tendons (4 strands; single incision; proximal fixation ‐ EndoButton; tibial fixation ‐ interference screw) | |
| Outcomes | Minimum 60 months follow‐up for: Tegner, KT‐2000 (maximum manual force and 134 N); range of motion, Lachman (0/1+/2+/3+); pivot shift; single‐leg hop; time required to return to sport and activity, complications, anterior knee pain, IKDC, radiographic, thigh circumference | |
| Notes | A third intervention group involving HT with extra‐articular plasty procedure in 25 patients is not included in this systematic review and meta‐analysis. Additional methodological information received comprised a confirmation of the number of re‐ruptures, graft failures and contralateral ruptures, and individual patient data for the following outcomes: Lachman, pivot shift test, re‐rupture/revisions. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Treatment allocation by alternate systematic sampling. The authors did not define what is meant by "alternate systematic sampling." |
| Allocation concealment (selection bias) | High risk | |
| Blinding (performance bias and detection bias) All outcomes | High risk | |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | High risk | Did not report contralateral ruptures or withdrawals. |
IKDC: International Knee Documentation Committee
Methods: if study does not specify assessment, assumed unblinded and not independent assessors
Lost to follow‐up: patients have unknown outcome; unclear on re‐ruptures in this group
Participants: n sizes listed are original randomized, not patients at follow‐up (unless indicated)