MRI study of bioabsorbable poly-L-lactic acid devices used for fixation of fracture and osteotomies.

Background: The overall clinical results of bioabsorbable fixation devices made of poly-L-lactic acid (PLLA) used for fixation of fractures, bone grafting, and osteotomies have been favorable. However, clinical studies demonstrated no sign of normal bony architecture restored after surgery, although implant channels had been filled with fibrous tissue. The purpose of the present retrospective study was to examine the extent of structural changes in PLLA devices (PLLA-Ds) for fixation of rotational acetabular osteotomies and displaced malleolar ankle fractures using magnetic resonance imaging (MRI).

Methods: Altogether, 14 patients with osteoarthritis of hip joints and 15 with displaced malleolar ankle fractures were operated on using PLLA-D (NEOFIX). Of these patients, 22 were finally enrolled in the study, and the period from operation to the time of the study ranged from 17 to 78 months. The postoperative radiographic findings were evaluated for union, and changes around the implant holes were classified as sclerosis, resorption, or no change. MRI was carried out to estimate changes in the PLLA-Ds.

Results: Bone union was obtained in all cases; clinical complications such as infection, joint effusion, soft tissue irritation due to PLLA-D deviation, and motion pain in the joints were not observed. The MRI study suggested that water content in PLLA-D increased mainly due to biodegradation and that implants were not replaced by bony tissue.

Conclusions: The PLLA-Ds were degraded but were not replaced by bony tissue during the observation period. Considering these findings and the assumption that in bony tissues mechanical strength of PLLA-D decreases with time, attention should be paid to mechanical insufficiency, which may occur when the cross-sectional area of a PLLA-D extends beyond the cross-sectional area of the osteosynthesis site.