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Published on: March 1, 2024
Pull-out strength of four tibial fixation devices used in anterior cruciate ligament reconstruction
M Chivot1, S Harrosch1, F Kelberine2
1Aix-Marseille université, CNRS, ISM UMR 7287, 13288 Marseille cedex 09, France; Service de chirurgie orthopédique et traumatologique, institut du mouvement et de la locomotion, hôpital Sainte-Marguerite, 270, boulevard Sainte-Marguerite, BP 29, 13274 Marseille, France.
Introduction:
In reconstructions of the anterior cruciate ligament (ACL), tibial fixation can be the weak point in the assembly during the early postoperative period. The present study sought to compare pull-out strength between four tibial fixation systems used in ACL reconstruction.
Hypothesis:
The study hypothesis was that all four devices show ≥450N pull-out strength with comparable biomechanical breakage characteristics.
Material And Methods:
An experimental study used a mechanical model to perform axial traction on a synthetic ligament (polypropylene cord folded in four) implanted in an artificial tibia (Sawbones Proximal Tibia # 1116-2: model: normal anatomy; solid foam; size: medium) using four tibial fixation systems: Ligafix® interference screw (SBM™); Bio-Intrafix® (Mitek™); Translig® (SBM™); RIGIDfix® (SBM™). For each system, four models were tested using an Instron 5566® traction machine, allowing 100mm/min stretching up to breakage. Study parameters comprised: pull-out strength, maximal whole assembly slippage, stiffness at breaking point, and type of break.
Results:
Mean pull-out strength was 450±24N (range, 421-488N) for Ligafix®, 415±60N (327-454N) for Bio-Intrafix®, 539±66N (449-636N) for RigidFix and 1067±211N (736-1301N) for Translig®, and was significantly greater for Translig® than for the other devices (p=0.02), which did not significantly differ from one another. The expected maximal load of 450N was reached in 100% of cases with Translig® and RIGIDfix® and in 50% of cases with Bio-Intrafix® and Ligafix®. There were no significant differences regarding stiffness. Ligafix® showed significantly less slippage than the others (p=0.006), with breakage caused by the ligament sliding between bone and implant.
Discussion:
In this in-vitro study, the Translig® fixation device showed better pull-out strength than the other three devices tested.
Type Of Study And Level Of Evidence:
Comparative laboratory study. Level II.
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