A new bioabsorbable interference screw: preliminary results of a prospective, multicenter, randomized clinical trial.

SUMMARY: A randomized clinical trial was conducted to compare a bioabsorbable polyglyconate screw (Endo-Fix; Smith & Nephew, Andover, MA) to a metal screw in anterior cruciate ligament reconstruction. A total of 124 patients were operated on and 113 assessed up to 1 year postoperatively. Assessments included a history and physical examination, the IKDC evaluation, and knee arthrometry measurements. No significant differences were found between the groups with respect to any of the IKDC problem areas at 1 year. The IKDC final evaluation was normal or nearly normal in 92% of polyglyconate patients and 90% of controls. The incidence of postoperative complications was similar in the 2 groups. One polyglyconate patient developed a subcutaneous cyst that may have been related to breakdown of the screw. This resolved without treatment and the patient had an excellent clinical outcome. This study shows that the polyglyconate screw is an effective alternative to metal in endoscopic reconstruction of the ACL.

RCT Entities:   Population Interventions Outcomes