OBJECTIVE: To compare the clinical effect of poly-DL-lactic acid (PDLLA) absorbable screws and titanium metallic screws in the treatment of syndesmotic disruptions in ankle fractures. METHODS: In this prospective, randomized clinical trial, 58 patients with or suspected of syndesmotic disruption associated with ankle fractures were randomly allocated to receive either bioabsorbable PDLLA or metallic titanium screwing fixation. Using preoperative radiography and intraoperative hook test, syndesmotic disruption was confirmed in 47 cases (25 with metallic screwing and 22 with PLLA screwing). Statistical analyses were performed at 6 months postoperatively to compare the AOFAS score, range of motion of the joint, TFCS width and TFO width on anteroposterior view radiographs, and inflammatory reactions between the two groups. RESULTS: The PDLLA screws showed good therapeutic effect similar to that of titanium metallic screws in syndesmosis fixation in these patients. No significant differences were found in the AOFAS score, range of motion of the joint, or TFCS width or TFO width between two groups (P>0.05). One patient in PDLLA screw group showed inflammatory reactions to the implants. CONCLUSION: PDLLA screws allow effective and reliable stabilization of syndesmotic disruptions without a second operation for screw removal.
RCT Entities:
OBJECTIVE: To compare the clinical effect of poly-DL-lactic acid (PDLLA) absorbable screws and titanium metallic screws in the treatment of syndesmotic disruptions in ankle fractures. METHODS: In this prospective, randomized clinical trial, 58 patients with or suspected of syndesmotic disruption associated with ankle fractures were randomly allocated to receive either bioabsorbable PDLLA or metallic titanium screwing fixation. Using preoperative radiography and intraoperative hook test, syndesmotic disruption was confirmed in 47 cases (25 with metallic screwing and 22 with PLLA screwing). Statistical analyses were performed at 6 months postoperatively to compare the AOFAS score, range of motion of the joint, TFCS width and TFO width on anteroposterior view radiographs, and inflammatory reactions between the two groups. RESULTS: The PDLLA screws showed good therapeutic effect similar to that of titanium metallic screws in syndesmosis fixation in these patients. No significant differences were found in the AOFAS score, range of motion of the joint, or TFCS width or TFO width between two groups (P>0.05). One patient in PDLLA screw group showed inflammatory reactions to the implants. CONCLUSION:PDLLA screws allow effective and reliable stabilization of syndesmotic disruptions without a second operation for screw removal.
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