Complications in the first 1043 operations where self-reinforced poly-L-lactide implants were used solely for tissue fixation in orthopaedics and traumatology

Abstract

This is an analysis from one hospital of the first 1043 operations where pure self-reinforced poly-Llactide (SR-PLLA) implants have been used alone. The operations were performed between 1988 and 1999 and included 407 orthopaedic patients and 636 trauma patients. There was a total of 107 complications. There were 21 infections but no sinus formation. Failure of fixation was seen in 46 patients. In 936 operations the healing was uneventful. IntroductionBioabsorbable fixation devices have been used clinically in bone fixation for 17 years. Presently, bioabsorbable implants are used with several indications in orthopaedics, sports medicine, and trauma surgery. This study is an analysis of the first 1043 operations where pure poly-L-lactide (SR-PLLA) implants have been used alone without any other implants. The study aims to clear up possible difficulties related to the use of bioabsorbable fixation devices in orthopaedics and traumatology. Material and methodsAll operations were performed at the Department of Orthopaedics and Traumatology, Helsinki University Central Hospital, during the years 1988-1999. The indication for operation was orthopaedic disorder (e.g. arthrodesis in rheumatoid arthritis, hallux valgus, and instability of the shoulder) in 407 patients, and trauma (mainly fractures and ligament ruptures) in 636 patients. The mean age was 43 years for orthopaedic patients and 37.7 years for trauma patients. In the orthopaedic series there were 294 women (72.2%) and in the trauma series 278 women (43.7%). All complications were counted, as were small variations from normal without any need for special treatment. Each complication was signed up separately, e.g. failure of fixation causing infection and further non-union were counted as three complications. ResultsThe results are summarised in Table 1. The average operation time in the orthopaedic series was 63 min and in the trauma series 48 min. A total of 55 complications (13.5%) was seen in the orthopaedic series (Table 2) and 52 (8.2%) in the trauma series (Table 3). The overall complication rate was 107/1043 (10.3%). Infection was seen in 13 orthopaedic and eight trauma patients (2%). Failure of fixation was found in 20 (4.9%) patients in the orthopaedic series and 26 (4.1%) in the trauma series. There were no sinus formations. No fluid accumulation was seen in orthopaedic patients whereas three trauma patients (0.5%) had fluid accumulation. Deep venous thrombosis was present in eight patients -three in the orthopaedic series and five in the trauma series. The postoperative healing was uneventful in 936 (89.7%) Statement on conflict of interest: No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article