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Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study.

ABSTRACT: 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.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.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.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.

SUBMITTER: Cox CL

PROVIDER: S-EPMC3903138 | biostudies-other | 2014 Feb

REPOSITORIES: biostudies-other

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Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study.

Cox Charles L CL Spindler Kurt P KP Leonard James P JP Morris Brent J BJ Dunn Warren R WR Reinke Emily K EK

The Journal of bone and joint surgery. American volume 20140201 3

<h4>Background</h4>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 radiog ...[more]

PMID: 24500587

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Project description:BackgroundBone-patellar tendon-bone (bone-tendon-bone) and four-strand hamstring tendon grafts (hamstring) are the most commonly utilized autografts for primary anterior cruciate ligament (ACL) reconstruction. Existing clinical trials, registry studies, and meta-analyses offer conflicting opinions regarding the most favorable graft choice.Questions/purposesWhich graft type for ACL reconstruction (bone-tendon-bone or hamstring) has a higher risk of (1) graft rupture and/or (2) graft laxity?MethodsWe performed a meta-analysis of randomized controlled trials (RCTs), prospective cohort studies, and high-quality national registry studies to compare the outcomes of primary ACL reconstruction with bone-tendon-bone autograft or hamstring autograft. Studies that compared these graft types were identified through a comprehensive search of electronic databases (PubMed, MEDLINE, EMBASE, and the Cochrane Library). Two independent reviewers utilized the Jadad scale for RCT study quality and the Modified Coleman Methodology Score for prospective comparative and registry study quality. The included studies were analyzed for the primary outcome measure of graft rupture with or without revision ACL surgery. In surviving grafts, secondary outcomes of graft laxity were quantified by KT1000/2000™ testing, a positive pivot shift test, and a positive Lachman test. Meta-analysis was performed with Review Manager. A total of 47,613 ACL reconstructions (39,768 bone-tendon-bone and 7845 hamstring) from 14 RCTs, 10 prospective comparative studies, and one high-quality national registry study were included in this meta-analysis. Mean age was 28 years in both groups. Sixty-three percent of patients in the bone-tendon-bone cohort were men versus 57% of patients in the hamstring cohort. Mean followup was 68 ± 55 months.ResultsTwo hundred twelve of 7560 (2.80%) bone-tendon-bone grafts ruptured compared with 1123 of 39,510 (2.84%) in the hamstring group (odds ratio = 0.83, 95% confidence interval, 0.72-0.96; p = 0.01). The number needed to treat analysis found that 235 patients would need to be treated with a bone-tendon-bone graft over a hamstring tendon graft to prevent one graft rupture. Instrumented laxity analysis showed that 22% (318 of 1433) of patients in the bone-tendon-bone group had laxity compared with 18% (869 of 4783) in the hamstring tendon group (odds ratio = 0.86; p = 0.16). Pivot shift analysis showed a positive pivot shift in 19% (291 of 1508) of the bone-tendon-bone group compared with 17% (844 of 5062) in the hamstring group (odds ratio = 0.89; p = 0.51). Lachman testing showed a positive Lachman in 25% (71 of 280) of patients receiving bone-tendon-bone grafts compared with 25% (73 of 288) in the hamstring group (odds ratio = 0.96; p = 0.84).ConclusionsIn this meta-analysis of short- to mid-term followup after primary ACL reconstruction, hamstring autografts failed at a higher rate than bone-tendon-bone autografts. However, failure rates were low in each group, the difference observed was small, and we observed few differences between graft types in terms of laxity. Both graft types remain viable options for primary ACL reconstruction, and the difference in failure rate should be one part of a larger conversation with each individual patient about graft selection that should also include potential differences in donor site morbidity, complication rates, and patient-reported outcome measures. Continued prospective collection of patient data will be important going forward as we attempt to further characterize the potential differences in outcomes attributable to graft selection.Level of evidenceLevel III, therapeutic study.

Project description:BackgroundAs our understanding of anterior cruciate ligament (ACL) anatomy has evolved, surgical techniques to better replicate the native anatomy have been developed. It has been proposed that the introduction of a rectangular socket ACL reconstruction to replace a ribbon-shaped ACL has the potential to improve knee kinematics after ACL reconstruction.PurposeTo compare a rectangular femoral tunnel (RFT) with a cylindrical femoral tunnel (CFT) in terms of replicating native ACL strain and knee kinematics in a time-zero biomechanical anatomic ACL reconstruction model using a bone-patellar tendon-bone (BTB) graft.Study designControlled laboratory study.MethodsIn total, 16 fresh-frozen, human cadaveric knees were tested in a 5 degrees of freedom, computed tomography-compatible joint motion simulator. Knees were tested with the ACL intact before randomization to RFT or CFT ACL reconstruction using a BTB graft. An anterior translation load and an internal rotation moment were each applied at 0°, 30°, 60°, and 90° of knee flexion. A simulated pivot shift was performed at 0° and 30° of knee flexion. Ligament strain and knee kinematics were assessed using computed tomography facilitated by insertion of zirconium dioxide beads placed within the substance of the native ACL and BTB grafts.ResultsFor the ACL-intact state, there were no differences between groups in terms of ACL strain or knee kinematics. After ACL reconstruction, there were no differences in ACL graft strain when comparing the RFT and CFT groups. At 60° of knee flexion with anterior translation load, there was significantly reduced strain in the reconstructed state ([mean ±standard deviation] CFT native, 2.82 ± 3.54 vs CFT reconstructed, 0.95 ± 2.69; RFT native, 2.77 ± 1.71 vs RFT reconstructed, 1.40 ± 1.76) independent of the femoral tunnel type. In terms of knee kinematics, there were no differences when comparing the RFT and CFT groups. Both reconstructive techniques were mostly effective in restoring native knee kinematics and ligament strain patterns as compared with the native ACL.ConclusionIn the time-zero biomechanical environment, similar graft strains and knee kinematics were achieved using RFT and CFT BTB ACL reconstructions. Both techniques appeared to be equally effective in restoring kinematics associated with the native ACL state.Clinical relevanceThese data suggest that in terms of knee kinematics and graft strain, there is no benefit in performing the more technically challenging RFT as compared with a CFT BTB ACL reconstruction.

Project description:BACKGROUND:The optimal positioning of anterior cruciate ligament graft is still controversially discussed. We therefore wanted to determine the tunnel-to-joint (TJA), tunnel-to-shaft (TSA), and graft-tunnel divergence angles which would provide the best outcome, determined by the KOOS (Knee Injury and Osteoarthritis Outcome Score). This study evaluated the clinical influence of graft orientation as measured with the KOOS questionnaire in patients with anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. METHODS:We designed a prospective cohort study, with a 1 ¼ year recruitment phase from March 2011 to July 2012 and a minimal follow-up period of 1 year. Inclusion criteria were patients ??18 years of age receiving an ACL reconstruction with bone-patellar tendon-bone autografts at our institution after having suffered an acute ACL rupture. The primary outcome was the KOOS. Independent variables were patient age, gender, laterality of rupture, mechanism of trauma, and type of femoral and tibial fixation, as well as sagittal graft-tunnel divergence, TJA, and TSA, the latter two being assessed on coronal slices of magnetic resonance imaging. Equations modeling the relationship between TJA, TSA, and graft-tunnel divergence with the KOOS overall score were fitted, and the optimum angles were mathematically determined. RESULTS:In total, 31 patients were included in our study. Our cohort with a median age of 28 years was predominantly male. The mathematically determined optimal placement of the implant in the coronal plane was a TJA of 74.8°, a TSA of 80.1°, and a graft-tunnel divergence angle of 8.5°. CONCLUSION:With regard to patient-reported outcome, the optimal graft orientation is provided by a coronal tunnel-to-shaft angle of 80° and tunnel-to-joint angle of 75°, respectively. Interestingly, in our series, patients reported best clinical outcomes with a sagittal graft-tunnel divergence. These results should be validated in larger studies.

Dataset Information

Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study.

Publications

Do newer-generation bioabsorbable screws become incorporated into bone at two years after ACL reconstruction with patellar tendon graft?: A cohort study.

Similar Datasets

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