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TightRope Versus Biocomposite Interference Screw for Fixation in Allograft ACL Reconstruction: Prospective Evaluation of Osseous Integration and Patient Outcomes.

ABSTRACT: Background:Anterior cruciate ligament (ACL) reconstruction is a commonly performed procedure with many options regarding graft choice and graft fixation. The purpose of this study was to compare suspensory and aperture fixation in terms of femoral osseous integration of the bone block after ACL reconstruction with an Achilles tendon allograft. Methods:After institutional review board approval and patient consent were obtained, 37 patients underwent ACL reconstruction with an Achilles tendon allograft. The patients were randomized according to the graft femoral fixation technique, which was with either a suspensory device (Arthrex TightRope) or aperture fixation by a biocomposite interference screw (Arthrex BioComposite Interference Screw or DePuy Mitek MILAGRO Interference Screw). Tibial fixation, performed with a biocomposite screw and knotless anchor, was identical in all patients. All patients underwent a computed tomography (CT) scan at 6 months to evaluate bone block incorporation of the femoral graft within the femoral tunnel, which was the study's primary outcome. Secondary outcome measures included a postoperative visual analogue scale (VAS) pain score, range-of-motion measures, and International Knee Documentation Committee scores. Demographic data were collected. Results:Thirty-three patients (89%) completed the study's 6-month follow-up, at which time the femoral ossification score was significantly greater in the aperture fixation group (p = 0.025). There was no substantial difference between the 2 groups with regard to any other outcome measure. Conclusions:Performing Achilles tendon allograft ACL reconstruction with femoral aperture fixation results in greater femoral bone block incorporation at 6 months postoperatively compared with what is seen after suspensory fixation. Level of Evidence:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

SUBMITTER: Yari SS

PROVIDER: S-EPMC7418916 | biostudies-literature | 2020 Apr-Jun

REPOSITORIES: biostudies-literature

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TightRope Versus Biocomposite Interference Screw for Fixation in Allograft ACL Reconstruction: Prospective Evaluation of Osseous Integration and Patient Outcomes.

Yari Shahram Shawn SS El Naga Ashraf N AN Patel Amar A Qadeer Ali Asaf AA Shah Anup A

JB & JS open access 20200402 2

<h4>Background</h4>Anterior cruciate ligament (ACL) reconstruction is a commonly performed procedure with many options regarding graft choice and graft fixation. The purpose of this study was to compare suspensory and aperture fixation in terms of femoral osseous integration of the bone block after ACL reconstruction with an Achilles tendon allograft.<h4>Methods</h4>After institutional review board approval and patient consent were obtained, 37 patients underwent ACL reconstruction with an Achil ...[more]

PMID: 33123662

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Project description:PURPOSE:Open or fenestrated interference screw design that allow bone ingrowth is a concept for improved bone healing to softtissue graft and bone filling in bone tunnels after anterior cruciate ligament reconstruction (ACLR) The aim of the current study was to assess CT scanning evaluated bone ingrowth into an open architecture interference screws in the tibial tunnel of patients undergoing ACL with soft tissue grafts. It was hypothesized that open architecture interference screws would stimulate bone ingrowth into the screw cavities. METHODS:Twelve patients requiring ACLR were included. They underwent arthroscopic ACLR with semitendinosus-/gracilis tendon graft and an open architecture polyetheretherketone (PEEK) interference screw. The patients were scanned with a multi-slice CT scanner two weeks, six and twelve months postoperatively. On CT reconstruction slices bone ingrowth into the screw was measured. Subjective and objective clinical outcome international knee documentation committee score and instrumented knee laxity determination were collected. RESULTS:At six months no implants demonstrated more than 10% bone ingrowth. At twelve months 42% (5/12) implants had more than 10% bone ingrowth (p?=?0.009). The average bone filling into the screws was 7.7%. There was no tunnel widening or cyst formation seen in relation to any of the implants. Subjective IKDC score improved significantly from 50.6 baseline to 80.1 at 24?month follow-up. Preoperative side-to-side knee laxity improved from 3.7 (2.1) to 1.4 (1.2) mm at twelve months. There were no serious adverse events in relation to the new open architecture thread PEEK interference screw during or after hamstring ACL reconstruction. CONCLUSION:The present study demonstrated that open architecture thread PEEK interference screw can stimulate bone ingrowth into the screws after soft tissue ACL reconstruction with at 12?months with an average bone filling into screws was 7.7%. Knee stability, functional, subjective and objective outcomes were similar to large volume ACL outcome studies. TRIAL REGISTRATION:The study was registered at ClinicalTrials # NCT02382341 . 12-09-2014. LEVEL OF EVIDENCE:IV.

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.

Project description: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).

Project description:BackgroundTibial aperture fixation with a bioabsorbable interference screw is a popular fixation method in anterior cruciate ligament reconstruction (ACLR). An interference screw containing β-tricalcium phosphate (β-TCP) to improve bony integration and biocompatibility was recently introduced. This study aims to compare the clinical outcomes and radiological results of tunnel enlargement effect between the 2 bioabsorbable fixative devices of pure poly-L-lactic acid (PLLA) interference screws and β-TCP-containing screws, for tibial interference fixation in ACLR using hamstring autografts.MethodsEighty consecutive patients who had undergone double-bundle ACLR between 2011 to 2012 were prospectively reviewed and randomly divided into two groups based on the type of tibial interference screw: 28 were assigned to the pure PLLA screw group (Group A), while the other 29 were assigned to the β-TCP-containing screw fixation group (Group B). Clinical evaluations and radiological analyses were conducted in both groups with a minimum 2- year follow-up.ResultsThere was no significant difference in subjective or objective clinical outcome between the 2 groups. In radiological analyses, the use of a β-TCP-containing screw reduced tunnel widening in the portion of the tunnel with screw engagement compared to the pure PLLA screw, while the use of a β-TCP-containing screw resulted in greater tunnel enlargement in the proximal portion of the tunnel without screw engagement than use of a pure PLLA screw.ConclusionUse of a β-TCP-containing interference screw in tibial aperture fixation reduced tunnel enlargement in the vicinity of the screw, whereas greater enlargement occurred proximal to the screw end relative to use of a pure PLLA interference screw. These paradoxical enlargements in use of β-TCP containing screws suggest that for reducing tunnel enlargement, the length of the interference screw should be as fit as possible with tunnel length in terms of using soft grafts.Level of evidenceII, Prospectively comparative study.Trial registrationRetrospectively registered with ClinicalTrials.gov. (NCT02754674) , Date of trial registration: February 10, 2016.

Dataset Information

TightRope Versus Biocomposite Interference Screw for Fixation in Allograft ACL Reconstruction: Prospective Evaluation of Osseous Integration and Patient Outcomes.

Publications

TightRope Versus Biocomposite Interference Screw for Fixation in Allograft ACL Reconstruction: Prospective Evaluation of Osseous Integration and Patient Outcomes.

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