Hoffmann R, Krettek C, Hetkämper A, Haas N, Tscherne H
Unfallchirurgische Klinik, Medizinischen Hochschule Hannover.
Unfallchirurg. 1992 Feb;95(2):99-105.
Forty distal fractures of the radius were stabilized with biodegradable polyglycolic acid rods (Biofix). A forearm plaster cast was fit for 4 weeks. Nine patients developed late (4 to 16 weeks) aseptic inflammatory reactions at the pin site, which were treated by débridement. The histological specimens showed giant-cell phagocytosing fragmented polyermic debris. In two cases a bacterial wound infection occurred secondary to débridement. All local reactions healed within 4 weeks. A classification system and treatment regimen for these inflammatory reactions are proposed. Thirty-four patients (including those with local foreign body reaction) were available for the 2-year follow-up. The anatomical results of fracture reduction on the postoperative and follow-up radiograms were the same, confirming good mechanical fracture stabilization. According to the Sarmiento score, the overall results were excellent and good in 31 cases. In one of the three fair cases, the result was clearly due to the initial local foreign-body reaction. Because of the high incidence of local inflammatory reaction, for now clinical application of biodegradable implants seems problematic despite the good overall 2-year results. This should only be advocated for well-controlled prospective studies using implants with improved biocompatibility.
采用可生物降解的聚乙醇酸棒（Biofix）对40例桡骨远端骨折进行固定。前臂石膏固定4周。9例患者在针道处出现晚期（4至16周）无菌性炎症反应，经清创治疗。组织学标本显示巨细胞吞噬破碎的聚合物碎片。2例患者在清创后发生伤口细菌感染。所有局部反应均在4周内愈合。提出了这些炎症反应的分类系统和治疗方案。34例患者（包括有局部异物反应的患者）进行了2年随访。术后及随访X线片上骨折复位的解剖学结果相同，证实骨折获得了良好的力学稳定性。根据Sarmiento评分，31例患者的总体结果为优或良。3例结果为一般的患者中，有1例显然是由于最初的局部异物反应所致。由于局部炎症反应发生率较高，尽管2年总体结果良好，但目前可生物降解植入物的临床应用似乎存在问题。这仅应在使用生物相容性改善的植入物的严格对照前瞻性研究中提倡。
