ArticleHeliyon2023
Anterior cruciate ligament reconstruction with a biocomposite interference screw maintains graft fixation survival and improves clinical outcomes at 1 year: A multicenter prospective case series.
Article in Heliyon, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed, 1 citations in OpenAlex.
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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