OBJECTIVES: To compare the performance of a metallic and a biodegradable screw in the fixation of tibia-fibula syndesmotic ruptures. DESIGN: A randomized, prospective, and blinded study. SETTING: Central hospital, Department of Surgery. PATIENTS: Forty consecutive patients with a clinically verified syndesmotic rupture in association with a malleolar fracture, of whom 38 completed the study. INTERVENTION: After syndesmosis rupture was diagnosed, implant selection was performed intraoperatively by a strict randomization with sealed envelopes. Eighteen patients were treated with ametallic screw, and 20 with a bioabsorbable polylevolactic acid screw. The metallic screws were removed in a second operation at 8 weeks postoperatively. All patients had a treatment-blinded clinical and radiographic control after a mean follow-up of 35 (range 17-51) months. MAIN OUTCOME MEASURES: Return to previous physical activity level, evaluation of ankle stability, range of motion, circumference of the ankle, and a radiographic evaluation of both ankles including a measure of the talocrural, medial joint, and syndesmotic space widths. RESULTS: More patients with a polylevolactic acid screw returned to their previous activity level, and there was less swelling in the ankles of these patients, but joint motion was similar between the groups. The mean values of syndesmotic and medial joint spaces were significantly higher in the radiographs of the operated ankles when compared to the uninjured ankle, but there was not a correlation to the type of screw used. CONCLUSIONS: Polylevolactic acid screws worked as well, or slightly better than, metallic ones in syndesmosis fixation in patients with an ankle fracture.
RCT Entities:
OBJECTIVES: To compare the performance of a metallic and a biodegradable screw in the fixation of tibia-fibula syndesmotic ruptures. DESIGN: A randomized, prospective, and blinded study. SETTING: Central hospital, Department of Surgery. PATIENTS: Forty consecutive patients with a clinically verified syndesmotic rupture in association with a malleolar fracture, of whom 38 completed the study. INTERVENTION: After syndesmosis rupture was diagnosed, implant selection was performed intraoperatively by a strict randomization with sealed envelopes. Eighteen patients were treated with a metallic screw, and 20 with a bioabsorbable polylevolactic acid screw. The metallic screws were removed in a second operation at 8 weeks postoperatively. All patients had a treatment-blinded clinical and radiographic control after a mean follow-up of 35 (range 17-51) months. MAIN OUTCOME MEASURES: Return to previous physical activity level, evaluation of ankle stability, range of motion, circumference of the ankle, and a radiographic evaluation of both ankles including a measure of the talocrural, medial joint, and syndesmotic space widths. RESULTS: More patients with a polylevolactic acid screw returned to their previous activity level, and there was less swelling in the ankles of these patients, but joint motion was similar between the groups. The mean values of syndesmotic and medial joint spaces were significantly higher in the radiographs of the operated ankles when compared to the uninjured ankle, but there was not a correlation to the type of screw used. CONCLUSIONS:Polylevolactic acid screws worked as well, or slightly better than, metallic ones in syndesmosis fixation in patients with an ankle fracture.
Authors: Bhaveen H Kapadia; Michael J Sabarese; Dipal Chatterjee; Alexandr Aylyarov; Daniel M Zuchelli; Omar K Hariri; Jaime A Uribe; Justin Tsai Journal: J Orthop Date: 2020-05-07