Bioabsorbable interference screws for graft fixation in anterior cruciate ligament reconstruction.

The central one third of the patellar tendon autograft is popular because the bone-tendon-bone (BTB) construct provides several graft fixation options, robust graft incorporation, and a mechanically sufficient substitute. Interference screw fixation is one method used to secure the graft. Bioabsorbable interference screws may offer advantages over metal interference screws. Bioabsorbable screws are made from poly L-lactic acid (PLLA) and are absorbed by the body. This prospective, randomized study compared the safety and efficacy of the PLLA screw with that of the metal cannulated interference screw for anterior cruciate ligament reconstruction. There were 204 patients randomly assigned to the Bioscrew (Linvatec, Largo, FL) (n = 103) or the metal interference screw (n = 101) groups at four sites. The mean age was 30 years. There were 66 women and 138 men. Mean follow-up was 30 months for Bioscrews and 28 months for metal screws; the average follow-up interval was 2.4 years. The Lysholm mean scores at 4 years for the 32 patients seen at this interval were 95.0 and 97.2 for the Bioscrew and metal screw group, respectively. Ligament laxity comparisons made with an instrumented arthrometer at manual maximum force resulted in side-to-side mean score differences of B = 1.8mm and M = 1.6mm. The Tegner activity level score means were B = 6.1 and M = 5.8. Other variables examined included pain, thigh size, meniscal tests, Lachman's test, range of motion, anterior drawer, pivot shift, patellofemoral crepitus and tenderness, and joint effusion. None of these variables showed a statistically significant difference between groups. No radiographic evidence of osteolytic change or bone resorption around the Bioscrews was observed. There were no complications related to loss of fixation, toxicity, allergenicity, or other evidence of osteolytic or inflammatory reaction. In every assessment between groups there was no difference found. There were 12 PLLA screws that broke during insertion without any adverse effects. The PLLA headless cannulated interference fit screws produce equal results to similarly designed metal screws.

RCT Entities:   Population Interventions Outcomes