Abstract
The accumulated clinical experience of biodegradable polymeric device’s application within 30 years made it possible to undertake a systematic research that would cover not only the immediate outcomes, but also the long-term results of this orthopedic surgeries. Objective. The present study was conducted to estimate long-term clinical and radiological outcomes, to identify possible adverse reactions or side-effects that might stem from the implanted biodegradable materials or from the products of their biodegradation. Materials and methods. The study involved 41 patients that had intra- or periarticular fractures of limbs and were operated using biodegradable devices with the follow-up period spanning from 1 to 27 years. In 37 cases domestically manufactured pins and screws made of polyglycolide (PGA) were used and in 4 cases – polylactide-polyglycolide (PLA/PGA) devices. The results were compared with metal osteosynthesis. Our modification of National Score System was used to estimate clinical and radiological (X-ray, computed tomography (CT), magnetic resonance imaging (MRI)) results. Results. The long-term clinical and radiological follow-up after internal fixation with PGA bone fracture fixation devices (BFFDs) revealed the higher score in patients with humeral condyles fractures (19.8 ± 0.6) and malleolus fractures (19.7 ± 0.5) compared with the control group of patients, who underwent internal fixation with metal devices – 18.0 ± 0.9 and 17.1 ± 0.8, respectively (P > 0.05). The similar results were revealed for PGA/PLA group with shorter follow-up period (from 1 to 3 years, P > 0.05). Conclusions. The early post-operative complications rate after polymeric osteosynthesis and metal osteosynthesis turned out to be similar, and there were no signs of its dependence on the kind of substance the device was made of. The second surgical intervention to remove metal devices affected the long-term follow-up results in this group. Bone structure in the places of PGA implantation was completely restored in operated patients. Further wide-ranging trials of various biodegradable fixation devices should be performed to determinate the preferable materials depending on the peculiarities of fracture site.
Highlights
MethodsThe study involved 41 patients that had intra- or periarticular fractures of limbs and were operated using biodegradable devices with the follow-up period spanning from 1 to 27 years
The accumulated clinical experience of biodegradable polymeric device’s application within 30 years made it possible to undertake a systematic research that would cover the immediate outcomes, and the long-term results of these orthopedic surgeries
Bone structure in the places of polyglycolic acid (PGA) implantation was completely restored in operated patients
Summary
The study involved 41 patients that had intra- or periarticular fractures of limbs and were operated using biodegradable devices with the follow-up period spanning from 1 to 27 years. There were three groups of patients involved in the study – PGA group included 37 patients (9 women, 28 men; women to men ratio – 1:3.1) in age from 31 to 76 (mean age 44.60 ± 10.79) where results were followed-up from 1 to 27 years (mean 16.30 ± 6.76). The second group included 4 patients operated with PGA/PLA BFFDs (3 women, 1 man) in age from 31 to 50 years (mean age 39.0 ± 8.2) with results that were followed-up for 1–3 years (mean 2.12 ± 0.85).
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