Adverse tissue reactions to bioabsorbable fixation devices. 2000

O M Böstman, and H K Pihlajamäki
Department of Orthopaedic and Trauma Surgery, University Hospital, Helsinki, Finland.

Among 2528 patients operated on using pins, rods, bolts, and screws made of polyglycolic acid or polylactic acid, 108 (4.3%) were affected by a clinically significant local inflammatory, sterile tissue reaction. The three most common indications for the use of these fixation devices were a displaced malleolar fracture, a chevron osteotomy for hallux valgus, and a displaced fracture of the radial head. In 107 patients, the reaction was elicited by a polyglycolic acid implant, and in one patient by a polylactic acid implant. The incidences were 5.3% (107 of 2037) and 0.2% (one of 491), respectively. The adverse tissue responses to polyglycolic acid were seen 11 weeks after the operation, on average, whereas the reaction to polylactic acid occurred 4.3 years after fixation of an ankle fracture. The mild reactions consisted of a painful erythematous papule of a few weeks' duration. Those of medium severity had a sinus that discharged remnants of the implant for up to 6 months. In the patients affected by severe reactions, extensive osteolytic lesions developed at the implant tracks. The histopathologic picture was that of a nonspecific foreign body reaction. In four patients with vigorous reactions, an arthrodesis of the wrist or ankle later was necessary because of severe osteoarthritis. Several markers of increased risk of the occurrence of a foreign body reaction were found. These included a poorly vascularized bone section such as scaphoid, use of a quinone dye as an additive in the polymer, and an implant geometry with large surface area (screw versus pin or rod). For polyglycolic acid implants, the risk of an adverse tissue response in a given clinical situation can be estimated from the findings of this study. For slow degrading polymers like polylactic acid, however, the ultimate biocompatibility still is unsettled, and additional clinical research with long followup is required.

UI MeSH Term Description Entries
D010014 Osteolysis Dissolution of bone that particularly involves the removal or loss of calcium. Osteolyses
D011091 Polyesters Polymers of organic acids and alcohols, with ester linkages--usually polyethylene terephthalate; can be cured into hard plastic, films or tapes, or fibers which can be woven into fabrics, meshes or velours. Polyester
D011100 Polyglycolic Acid A biocompatible polymer used as a surgical suture material. Polyglycolide,Biofix,Dexon (Polyester),Dexon-S,Dexon S,DexonS
D011108 Polymers Compounds formed by the joining of smaller, usually repeating, units linked by covalent bonds. These compounds often form large macromolecules (e.g., BIOPOLYMERS; PLASTICS). Polymer
D012086 Reoperation A repeat operation for the same condition in the same patient due to disease progression or recurrence, or as followup to failed previous surgery. Revision, Joint,Revision, Surgical,Surgery, Repeat,Surgical Revision,Repeat Surgery,Revision Surgery,Joint Revision,Revision Surgeries,Surgery, Revision
D001842 Bone and Bones A specialized CONNECTIVE TISSUE that is the main constituent of the SKELETON. The principal cellular component of bone is comprised of OSTEOBLASTS; OSTEOCYTES; and OSTEOCLASTS, while FIBRILLAR COLLAGENS and hydroxyapatite crystals form the BONE MATRIX. Bone Tissue,Bone and Bone,Bone,Bones,Bones and Bone,Bones and Bone Tissue,Bony Apophyses,Bony Apophysis,Condyle,Apophyses, Bony,Apophysis, Bony,Bone Tissues,Condyles,Tissue, Bone,Tissues, Bone
D003238 Connective Tissue Tissue that supports and binds other tissues. It consists of CONNECTIVE TISSUE CELLS embedded in a large amount of EXTRACELLULAR MATRIX. Connective Tissues,Tissue, Connective,Tissues, Connective
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D005549 Foreign-Body Reaction Chronic inflammation and granuloma formation around irritating foreign bodies. Foreign Body Reaction,Reaction, Foreign-Body
D005593 Fracture Fixation, Internal The use of internal devices (metal plates, nails, rods, etc.) to hold the position of a fracture in proper alignment. Osteosynthesis, Fracture,Fixation, Internal Fracture,Fixations, Internal Fracture,Fracture Fixations, Internal,Fracture Osteosyntheses,Fracture Osteosynthesis,Internal Fracture Fixation,Internal Fracture Fixations,Osteosyntheses, Fracture

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