Clinical Equivalence of Clinifibre® and FiberWire® Ultra-High Molecular Weight Polyethylene Suture for Graft Preparation in Unilateral Anterior Cruciate Ligament Reconstruction: A Single-Blind Randomized Study

TL;DR

This study compares two types of sutures used in knee ligament surgery and finds they have similar clinical results.

Contribution

Demonstrates clinical equivalence between Clinifibre® and FiberWire® sutures in ACL reconstruction outcomes.

Findings

No significant difference in surgical site infection rates between the two suture groups.

Both sutures showed comparable functional outcomes and recovery metrics.

No revision surgeries were required in either group during the study period.

Abstract

Introduction

Arthroscopic anterior cruciate ligament reconstruction (ACLR) is the gold standard for restoring rotational stability of the injured knee. The success of ACLR depends on surgical preparation and technique and is indicated by post-operative complications and functional outcomes. The study investigated the clinical equivalence of Clinifibre® and FiberWire® ultra-high molecular weight polyethylene (UHMWPE) sutures for graft preparation during unilateral primary ACLR.

Methods

Skeletally mature adults (18-50 years) undergoing unilateral primary ACLR with hamstring autograft were randomized to Clinifibre® (n=36) and FiberWire® (n=36) groups (March 2022 to September 2024). The primary endpoints, surgical site infection (SSI) and revision surgery due to ACL graft failure, were assessed, along with Lachman test, pivot shift test, hospital stay, single leg-hop test, scores of Lysholm knee, Tegner activity, International Knee Documentation Committee subjective knee evaluation form, pain, Knee Osteoarthritis and Outcomes Score quality of life (KOOS-QOL), intraoperative and post-operative complications, suture handling characteristics, return to normal activities, return to work, return to pre-injury sports, mobilization period with crutches, and adverse events. The level of significance was tested at p<0.05.

Results

The rate of SSI (at skin suturing site) was not significantly different between the groups and was found only in one subject in the FiberWire® group. During the study, revision surgery was not required in either arm. Return to day-to-day activity, return to work, return to pre-injury sports, and mobilization with crutches and single leg-hop score were comparable. The ACLR has improved anteroposterior laxity, rotational stability, KOOS-QOL, pain, and knee-related scoring in both groups.

Conclusion

The primary and secondary outcomes confirmed clinical equivalence of Clinifibre® and FiberWire® sutures. An overall recovery concerning laxity, pain, knee stability, KOOS-QOL, and functional outcomes further affirmed the efficacy of UHMWPE sutures for graft preparation during primary ACLR.

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