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Biocomposite Interference Screws in Anterior Cruciate Ligament Reconstruction: Osteoconductivity and Degradation.

ABSTRACT: Purpose:To evaluate the long-term in vivo degradation of an amorphous stereoisomer combined with micro ?-tricalcium phosphate poly levo (96%)/dextro (4%) lactide beta-tricalcium phosphate biocomposite interference screw. Methods:A study approved by the institutional review board of in vivo biologic behavior of the screw was initiated in 2011 using an anterior cruciate ligament (ACL) reconstruction model. Twenty patients undergoing bone-patellar tendon-bone ACL reconstruction fixed at the femur and tibia with these biocomposite screws followed at least 36 months were evaluated by physical, radiographic, and computed tomography (CT) evaluations. Lysholm, Tegner, Cincinnati, and International Knee Documentation Committee scores were obtained. CT Hounsfield unit (HU) data were obtained at the femoral and tibial screw and other bone sites. An ossification quality score (range 1-4) was used to determine osteoconductivity at the screw sites. Results:In total, 11 male and 9 female patients evaluated by CT scan and radiographs a mean of 41 months postsurgery (range, 37-51) showed bone plug healing to the tunnel wall and the screw replaced with calcified and nontrabecular material. Osteoconductivity was present in 34 of 40 tunnels (85%) and nearly complete or complete (type 3 or 4 ossification) in 10 of 40 (25%). Mean screw-site densities (femoral 239 HU; tibial 290 HU) were consistent with cancellous bone density. One positive pivot-shift test was found. Lysholm, Cincinnati, Tegner, and International Knee Documentation Committee activity scores improved from 46.9, 43.5, 1.9, and 1.7 preoperatively to 92, 90.2, 6.0, and 3.2 at follow-up, respectively. The average postoperative Single Assessment Numeric Evaluation score was 86 and mean KT-1000 arthrometer difference was 0.32 mm. Conclusions:The micro ?-tricalcium phosphate poly levo (96%)/dextro (4%) lactide beta-tricalcium phosphate interference screw was replaced by calcified, nontrabecular material a mean of 42 months after implantation in a bone-patellar tendon-bone ACL reconstruction model. Osteoconductivity was confirmed. Level of Evidence:Level IV (therapeutic case series).

SUBMITTER: Barber FA

PROVIDER: S-EPMC7190552 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Biocomposite Interference Screws in Anterior Cruciate Ligament Reconstruction: Osteoconductivity and Degradation.

Barber F Alan FA Dockery W D WD

Arthroscopy, sports medicine, and rehabilitation 20200130 2

<h4>Purpose</h4>To evaluate the long-term in vivo degradation of an amorphous stereoisomer combined with micro β-tricalcium phosphate poly levo (96%)/dextro (4%) lactide beta-tricalcium phosphate biocomposite interference screw.<h4>Methods</h4>A study approved by the institutional review board of in vivo biologic behavior of the screw was initiated in 2011 using an anterior cruciate ligament (ACL) reconstruction model. Twenty patients undergoing bone-patellar tendon-bone ACL reconstruction fixed ...[more]

PMID: 32368739

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Project description:A biocomposite interference screw with an open architecture was developed to provide a greater available surface area for bone ingrowth compared with conventional solid interference screws. We herein describe a prospective, single-cohort study conducted using this interference screw in anterior cruciate ligament (ACL) reconstruction. Sixty subjects (mean age, 34.9 years; standard deviation, 10.6) undergoing ACL repair using the biocomposite interference screw were enrolled at 3 sites in the United States. Subjects were followed preoperatively (baseline) and postoperatively at 6 months and 1 year. The primary endpoint was graft fixation survival rate at 6 months and 1 year. Secondary endpoints included graft survival (failure defined as that occurring for any reason); International Knee Documentation Committee (IKDC) score (exam and subjective forms); Tegner Activity form; Lysholm score; and EQ (EuroQuol)-5D-5L index score and visual analogue scale. There was a 100 % rate of graft fixation survival at 6 months (54/54; 95 % confidence interval [CI]: 100-100) and 1 year (50/50; 95 % CI: 100-100). One patient experienced a complete tear of the ACL 5 months following index surgery, resulting in graft survival rates of 98.1 % (53/54; 95 % CI: 94.6-100) at 6 months at 98.0 % (49/50; 95 % CI: 94.1-100) at 1 year. Significant improvements (p < .0001) were obtained between baseline and 6 months for the majority of patient-reported outcomes, and were maintained out to 1-year follow up. There was no significant difference over baseline in the IKDC sub-scale of symptoms. Nine patients (15.0 %) experienced serious adverse events during the course of the study; three of these patients' adverse events were considered possibly or definitely related to the procedure device (ACL tear, pulmonary embolism/deep vein thrombosis, and a patellar fracture). In conclusion, this biocomposite interference screw has a favorable safety and efficacy profile at 1 year, with no failures of graft fixation, noted during that time.

Dataset Information

Biocomposite Interference Screws in Anterior Cruciate Ligament Reconstruction: Osteoconductivity and Degradation.

Publications

Biocomposite Interference Screws in Anterior Cruciate Ligament Reconstruction: Osteoconductivity and Degradation.

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