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.
1Vanderbilt Sports Medicine, Vanderbilt University Medical Center, 4200 Medical Center East, South Tower, Nashville, TN 37232. E-mail address for K.P. Spindler: firstname.lastname@example.org