BACKGROUND:Self-reinforced poly(L/dL)lactide 70:30 (SR-PLA70) retains its strength in bone for 24 weeks, whereas self-reinforced poly-L-lactide (SR-PLLA) retains its strength for over 36 weeks. In this prospective randomized study, bioabsorbable 4.5-mm SR-PLA70 screws were compared with SR-PLLA screws in the treatment of displaced ankle fractures in adults. METHODS:Sixty-two patients with ankle fractures needing operative treatment were randomized into two groups. Comminuted fractures needing plating were excluded. In total 54 of 62 patients were followed up for 1 year by clinical evaluation, radiographs, and Olerud-Molander score. RESULTS: The study groups differed significantly only in the mean duration of sick leave (SR-PLA70, 60 days; SR-PLLA, 65 days; P = 0.02). At the 1-year follow-up, syndesmotic ossification was more common in the SR-PLA70 group (5 versus 1 patient, not significant). Radiologically, the screw channel had not disappeared in any of the patients by the 1-year follow-up. CONCLUSIONS: Both implant types proved to have good biocompatibility. SR-PLA70 and SR-PLLA screws are suitable in selected cases for the fixation of ankle fractures, but the mechanical stability of the fixation has to be carefully monitored perioperatively.
RCT Entities:
BACKGROUND: Self-reinforced poly(L/dL)lactide 70:30 (SR-PLA70) retains its strength in bone for 24 weeks, whereas self-reinforced poly-L-lactide (SR-PLLA) retains its strength for over 36 weeks. In this prospective randomized study, bioabsorbable 4.5-mm SR-PLA70 screws were compared with SR-PLLA screws in the treatment of displaced ankle fractures in adults. METHODS: Sixty-two patients with ankle fractures needing operative treatment were randomized into two groups. Comminuted fractures needing plating were excluded. In total 54 of 62 patients were followed up for 1 year by clinical evaluation, radiographs, and Olerud-Molander score. RESULTS: The study groups differed significantly only in the mean duration of sick leave (SR-PLA70, 60 days; SR-PLLA, 65 days; P = 0.02). At the 1-year follow-up, syndesmotic ossification was more common in the SR-PLA70 group (5 versus 1 patient, not significant). Radiologically, the screw channel had not disappeared in any of the patients by the 1-year follow-up. CONCLUSIONS: Both implant types proved to have good biocompatibility. SR-PLA70 and SR-PLLA screws are suitable in selected cases for the fixation of ankle fractures, but the mechanical stability of the fixation has to be carefully monitored perioperatively.
Authors: Eun Ji Chung; Hongjin Qiu; Pradeep Kodali; Scott Yang; Stuart M Sprague; James Hwong; Jason Koh; Guillermo A Ameer Journal: J Biomed Mater Res A Date: 2010-10-14 Impact factor: 4.396