Bioabsorbable osteosynthetic implants of ultra high strength poly-L-lactide. A clinical study.
We have developed reasonably strong but bioabsorbable osteosynthetic screws, pins and nails made of ultra high strength poly-L-lactide (PLLA) and evaluated their use in 143 patients. The PLLA implants have the highest strength among those reported to date. They lose about 10% of their initial strength within 8 weeks, about 40% within 4 weeks and nearly 100% within 20 weeks in vivo. The patients were aged from 9 to 78 years, and the follow up was from 2 to 6 years. The implants were used for fixation of bone grafts in 84 patients, peri- and intra-articular fractures in 49, after osteotomy in 8, and in 2 others. Bony union was not achieved in only one case. In the early stages of the study, breakage of screws occurred in 12 cases (8%), mostly because of an inappropriate size of tap; these problems have not occurred after improvement of the tapping system. There were no cases with abnormal blood tests, infection or foreign body reaction.
Yamamuro
T
T
Department of Orthopaedic Surgery, Faculty of Medicine, Kyoto University, Japan.
Matsusue
Y
Y
Uchida
A
A
Shimada
K
K
Shimozaki
E
E
Kitaoka
K
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D001672:Biocompatible Materials; D001673:Biodegradation, Environmental; D016025:Bone Transplantation / Q000295:instrumentation; D002648:Child; D005260:Female; D005593:Fracture Fixation, Internal / Q000295:instrumentation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009984:Orthopedic Fixation Devices; D010027:Osteotomy / Q000295:instrumentation; D011091:Polyesters / Q000627:therapeutic use*; D019736:Prostheses and Implants
D001672:Biocompatible Materials; D011091:Polyesters; C033616:poly(lactide)