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Scientific Articles   |    
Do Newer-Generation Bioabsorbable Screws Become Incorporated into Bone at Two Years After ACL Reconstruction with Patellar Tendon Graft?A Cohort Study
Charles L. Cox, MD, MPH1; Kurt P. Spindler, MD1; James P. Leonard, MD1; Brent J. Morris, MD1; Warren R. Dunn, MD, MPH1; Emily K. Reinke, PhD1
1 Vanderbilt Sports Medicine, Vanderbilt University Medical Center, 4200 Medical Center East, South Tower, Nashville, TN 37232. E-mail address for K.P. Spindler: kurt.spindler@vanderbilt.edu
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  • Disclosure statement for author(s): PDF

Investigation performed at Vanderbilt Sports Medicine, Vanderbilt University Medical Center, Nashville, Tennessee



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, one or more of the authors has had another relationship, or has engaged in another activity, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2014 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2014 Feb 05;96(3):244-250. doi: 10.2106/JBJS.L.01652
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Abstract

Background: 

Bioabsorbable interference screws are used frequently for graft fixation in ACL (anterior cruciate ligament) reconstruction. The resorption properties of many available screws that are marketed as bioabsorbable are not well defined. The CALAXO (Smith & Nephew Endoscopy) and MILAGRO (DePuy Synthes) bioabsorbable screws contain polymers of poly(lactic-co-glycolic acid) (PLGA) plus additives to encourage osseointegration over time. The purpose of this study was to evaluate radiographic and magnetic resonance imaging (MRI) properties and compare patient-reported outcomes at a minimum of two years of follow-up after ACL reconstruction using CALAXO or MILAGRO bioabsorbable interference screws.

Methods: 

A cohort of patients who underwent ACL reconstruction in which the fixation used was either CALAXO or MILAGRO screws returned for repeat radiographs for evaluation of tunnel widening, repeat MRI for evaluation of graft integrity and screw breakdown, and completion of the pain and symptom items of the KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire.

Results: 

At a mean of three years (range, 2.5 to 4.0 years) after surgery, thirty-one patients with sixty-two CALAXO screws and thirty-six patients with seventy-two MILAGRO screws returned for repeat evaluation. Two blinded, independent reviewers found no significant differences between the two screw types when comparing radiographs for tibial or femoral tunnel widening or MRIs for graft integrity, tibial and femoral foreign body reactions, or femoral screw degradation. Both reviewers found a significant difference between the two screw types when comparing tibial screw degradation properties (p < 0.01). All analyzed CALAXO screws were rated as partially intact or degraded; the MILAGRO screws were more likely to be rated as intact. No significant differences were noted between the two screw types when comparing the two KOOS subscales.

Conclusions: 

CALAXO screws in the tibial tunnel were more likely to be rated as degraded or partially degraded compared with MILAGRO screws at a mean of three years after implantation for ACL reconstruction. Although these newer-generation bioabsorbable screws were designed to promote osseointegration, no tunnel narrowing was noted, and in the majority of cases the remains of the screws were present at approximately three years.

Level of Evidence: 

Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Peer Review: 

This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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