JBJS | Late Foreign-Body Reaction to an Intraosseous Bioabsorbable Polylactic Acid Screw. A Case Report*

The Journal of Bone & Joint Surgery, Volume 80, Issue 12

Articles | December 01, 1998

Late Foreign-Body Reaction to an Intraosseous Bioabsorbable Polylactic Acid Screw. A Case Report*

OLE M. BÖSTMAN, M.D.†; HARRI K. PIHLAJAMÄKI, M.D.†, HELSINKI, FINLAND

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Investigation performed at the Department of Orthopaedic and Trauma Surgery, Helsinki University Hospital, Helsinki

The Journal of Bone & Joint Surgery. 1998; 80:1791-4

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Introduction

Introduction | Case Report | Discussion | References

Local inflammatory and osteolytic foreign-body reactions to bioabsorbable implants made of polyglycolic acid have been well documented in the literature^4,5,8,12. Rapid degradation of the polyglycolic acid polymer causes these adverse reactions to occur within two to four months after implantation, when the disintegration of the polymer has reached its final phase^6,19.

Polylactic acid is another synthetic biodegradable polymer used in fracture-fixation implants. In contrast to polyglycolic acid, the degradation time of the stereo-isomeric form of polylactic acid that is used most commonly, poly-L-lactic acid, is several years. Consequently, the possible foreign-body reactions to devices made of poly-L-lactic acid can be expected to emerge much later than the reactions to devices made of polyglycolic acid. Because implants made of poly-L-lactic acid have been used clinically on a widespread basis for less than ten years, knowledge of the long-term biocompatibility of this polymer in human tissues is limited. We report the case of a patient in whom a local inflammatory reaction to a poly-L-lactic acid screw occurred more than four years after the fixation of an ankle fracture.

*One or more of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. In addition, benefits have been or will be directed to a research fund or foundation, educational institution, or other nonprofit organization with which one or more of the authors is associated. Funds were received in total or partial support of the research or clinical study presented in this article. The funding source was The Helsinki University Hospital Research Funds.

†Department of Orthopaedic and Trauma Surgery, Helsinki University Hospital, Topeliuksenkatu 5, FIN-00260, Helsinki, Finland. E-mail address for Dr. Böstman: ole.bostman@helsinki.fi.

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Fig. 1 Anteroposterior radiograph of the left ankle, showing a displaced bimalleolar fracture.

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Fig. 2 Anteroposterior radiograph of the ankle, made fifty-two months after the procedure, showing a poorly defined osteolytic lesion corresponding to the screw track in the lateral malleolus (asterisk).

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Fig. 3 Photomicrograph of the excised granulomatous lesion. Polarized light microscopy demonstrated an abundance of birefringent polymeric particles of different sizes within macrophages and within multinucleated foreign-body giant cells. The largest fragments (asterisk) lie in the extracellular compartment (Masson-Goldner trichrome, x 3500).

Case Report

Introduction | Case Report | Discussion | References

A twenty-eight-year-old woman sustained a closed, displaced bimalleolar fracture of the left ankle when she slipped on ice in January 1991 (Fig. 1). She had insulin-dependent diabetes mellitus but was otherwise healthy at the time of injury. On the day of admission, the fracture fragments were anatomically reduced and fixed with bioabsorbable poly-L-lactic acid screws (Bioscience, Tampere, Finland). The fracture was exposed, under tourniquet control, through longitudinal incisions over the malleoli. The lateral malleolus was fixed with one 4.5 by fifty-millimeter interfragmentary screw, and the medial malleolus was fixed with one 4.5 by forty-millimeter interfragmentary screw. The screw that was used for the lateral malleolus was inserted diagonally in an anteroposterior direction in the sagittal plane, across the fracture surfaces, for interfragmental compression¹⁵. A countersink was used, but the head of the screw was not shaved with a loop cautery or a rongeur. The postoperative course was unremarkable, and the operative wound healed normally. The patient wore a plaster cast for six weeks; partial weight-bearing was allowed after three weeks, and full weight-bearing was allowed after four weeks. Complete recovery of ankle motion and function was recorded at ten weeks.

In May 1995, fifty-two months after the procedure, the patient had local pain on the lateral side of the ankle. Within a week, a tender, poorly demarcated erythematous papule, 1.5 centimeters in diameter, developed in the lateral malleolus, over the entrance point of the screw. The erythrocyte sedimentation rate and the serum concentration of C-reactive protein were each measured three times. The highest erythrocyte sedimentation rate measured was twenty-five millimeters per hour (normal, less than eleven millimeters per hour). The serum concentration of C-reactive protein was normal (less than ten milligrams per liter) each time it was measured. Plain radiographs and computed tomographic scans showed a poorly defined, multilobular osteolytic lesion corresponding to the course of the screw track in the lateral malleolus (Fig. 2). Needle aspiration of the papule yielded no fluid for bacterial culture. During the next four months, the local symptoms and findings remained unchanged. No sinus tract to the skin developed. The patient was able to bear full weight on the leg, and the range of motion of the ankle joint was normal. No symptoms or signs were present on the medial side of the ankle. The patient requested removal of the persistent, painful papule.

At the time of exploration, in October 1995, a one-centimeter-diameter granulomatous lesion that was composed of relatively firm connective tissue was found at the entrance hole of the screw track; the lesion was partly extraosseous and partly intraosseous. The lesion was excised, and the bone was curetted. No remnants of the implant could be seen macroscopically, but histological examination revealed an abundance of polymeric particles that were birefringent under polarized light (Fig. 3). Particles that were smaller than four micrometers in diameter were located within the cytoplasm of mononuclear macrophages. Larger particles were surrounded by multinucleated foreign-body giant cells. The largest polymeric particles, thirty to forty micrometers in diameter, were found in the extracellular space with few surrounding reactive cells. The cell population was composed mainly of macrophages. Lymphocytes comprised approximately 10 percent of all identifiable cells. Immunohistochemical analysis showed the lymphocytes to be CD3-positive and L26-negative; this antigenic marker pattern is typical of T-lymphocytes. The overall histological picture was indicative of a nonspecific foreign-body reaction. There was no evidence of an infection or a malignant lesion.

At the latest follow-up examination, in October 1997, there was still tenderness over the lateral malleolus without any swelling or erythema. On plain radiographs, the area of decreased bone density in the lateral malleolus was unchanged.

Discussion

Introduction | Case Report | Discussion | References

Polylactic acid biodegrades by simple, random hydrolytic scission of the ester bonds in the polymer chain. The monomeric lactic acid that results can be oxidized to pyruvic acid and can thereby enter the tricarboxylic acid cycle for ultimate elimination as carbon dioxide and water. With regard to the phagocytic and clearing capacity of the tissues, the most demanding phase is the decomposition stage, when the gross geometry of the implant is rapidly lost. At that time, the rate of production of polymeric debris may exceed the critical limits of the ability of the surrounding tissues to phagocytize and metabolize the hydrolyzed polymeric chains.

Poly-L-lactic acid materials from different sources may differ in terms of thermal history, polymeric structure, molecular weight, and degree of crystallinity. These factors, in turn, influence the rate of degradation and the tissue response^3,14,16. The rate of degradation of poly-L-lactic acid implants has not been determined precisely. In an experimental study, high-strength poly-L-lactic acid rods that had been implanted in the medullary cavity of rabbit femora resorbed completely by sixty-two months but only partially by forty-two months¹⁴. In a clinical study, late exploration showed that poly-L-lactic acid plates were not fully absorbed as long as 5.7 years after fixation of a zygomatic fracture³.

To our knowledge, we are the first to describe a late foreign-body reaction to a solitary intraosseous poly-L-lactic acid screw. Intermittent painless local swelling has been reported to occur at the site of extraosseous poly-L-lactic acid plates used for the fixation of zygomatic fractures³ and ankle fractures¹⁰. The reactions reported in association with the use of poly-L-lactic acid plates for the fixation of fractures of the lateral malleolus were seen as early as one year after the operation¹⁰. By decreasing the size of the poly-L-lactic acid plates, that same group of researchers was able to eliminate clinically evident adverse tissue responses¹¹.

In a series of eighty-three patients in whom a medial malleolar fracture had been fixed with poly-L-lactic acid screws, one patient had local swelling over the screw heads fifteen months after the operation⁹. A cystic mass was excised, and histological examination showed fragmented polymeric material and abundant macrophages. In a study of fifty-one patients in whom a displaced fracture of the ankle had been treated with poly-L-lactic acid screws, one patient had mild local erythema on the lateral side of the ankle over a subcutaneous screw head twenty-two months after fixation; the reaction spontaneously subsided within four weeks⁷.

The reported reactions^3,10 to extraosseous poly-L-lactic acid material probably were biologically different from the reaction described here, which was a late tissue response to a mainly intraosseous screw. An intraosseous location of bioabsorbable polymeric material is likely to result in a different mechanism for the clearance of debris, neoangiogenesis, and ultimate replacement of the implant with tissue when compared with an extraosseous location. The findings in our patient also clearly differed from the purely mechanical discomfort caused by prominent subcutaneous screw heads in a few of the patients in the two previously mentioned studies in which fractures of the ankle were treated with poly-L-lactic acid implants^7,9. However, the minimum durations of follow-up in those two studies (two and three years) were too short to allow detection of any late foreign-body reactions or to permit any definitive conclusions regarding the biocompatibility of poly-L-lactic acid.

It has been suggested that poly-L-lactic acid has adverse immunological complement-activating potential¹⁸, but the data on this issue are controversial¹³. The fact that the late foreign-body reaction in the present report occurred only on the lateral side of the ankle suggests that the response represented a local overload of polymeric debris rather than an immunologically mediated sensitivity to the polymer.

The clinical use of poly-L-lactic acid implants has increased, not only in fracture fixation but also in new applications such as operative treatment of instability of the shoulder¹⁷, arrow repair of meniscal lesions¹, and reconstruction of the anterior cruciate ligament with use of interference screws². Orthopaedic surgeons should be aware of the possibility of late foreign-body reactions to bioabsorbable implants that have a long degradation time.

References

Introduction | Case Report | Discussion | References

Albrecht-Olsen, P.; Lind, T.; Kristensen, G.; and Falkenberg, B.: Failure strength of a new meniscus arrow repair technique. Biomechanical comparison with horizontal suture. Arthroscopy,13: 183-187, 1997.13183 1997 [PubMed][CrossRef]

Barber, F. A.; Elrod, B. F.; McGuire, D. A.; and Paulos, L. E.: Preliminary results of an absorbable interference screw. Arthroscopy,11: 537-548, 1995.11537 1995 [PubMed][CrossRef]

Bergsma, J. E.; de Bruijn, W. C.; Rozema, F. R.; Bos, R. R.; and Boering, G.: Late degradation tissue response to poly(L-lactide) bone plates and screws. Biomaterials,16: 25-31, 1995.1625 1995 [PubMed][CrossRef]

Böstman, O.; Hirvensalo, E.; Mäkinen, J.; and Rokkanen, P.: Foreign-body reactions to fracture fixation implants of biodegradable synthetic polymers. J Bone and Joint Surg.,72-B(4): 592-596, 1990.72-B(4)592 1990

Böstman, O. M.: Current concepts review. Absorbable implants for the fixation of fractures. J. Bone and Joint Surg.,73-A: 148-153, Jan. 1991.73-A148 1991

Böstman, O.; Päivärinta, U.; Partio, E.; Vasenius, J.; Manninen, M.; and Rokkanen, P.: Degradation and tissue replacement of an absorbable polyglycolide screw in the fixation of rabbit femoral osteotomies. J. Bone and Joint Surg.,74-A: 1021-1031, Aug. 1992.74-A1021 1992

Böstman, O. M.; Pihlajamäki, H. K.; Partio, E. K.; and Rokkanen, P. U.: Clinical biocompatibility and degradation of polylevolactide screws in the ankle. Clin. Orthop.,320: 101-109, 1995.320101 1995 [PubMed]

Böstman, O. M.: Osteoarthritis of the ankle after foreign-body reaction to absorbable pins and screws. A three- to nine-year follow-up study. J. Bone and Joint Surg.,80-B(2): 333-338, 1998.80-B(2)333 1998 [CrossRef]

Bucholz, R. W.; Henry, S.; and Henley, M. B.: Fixation with bioabsorbable screws for the treatment of fractures of the ankle. J. Bone and Joint Surg.,76-A: 319-324, March 1994.76-A319 1994

Eitenmüller, J.; Dávid, A.; Pommer, A.; and Muhr, G.: Die Versorgung von Sprunggelenksfrakturen unter Verwendung von Platten und Schrauben aus resorbierbarem Polymer-material. Hefte Unfallheilk.,212: 440-443, 1990.212440 1990

Eitenmüller, J.; David, A.; Pommer, A.; and Muhr, G.: Operative Behandlung von Sprunggelenksfrakturen mit biodegradablen Schrauben und Platten aus Poly-L-Lactid. Chirurg,67: 413-418, 1996.67413 1996 [PubMed]

Hovis, W. D., and Bucholz, R. W.: Polyglycolide bioabsorbable screws in the treatment of ankle fractures. Foot and Ankle Internat.,18: 128-131, 1997.18128 1997

Mainil-Varlet, P.: Polylactic acid pins [letter; comment]. Acta Orthop. Scandinavica,66: 573-574, 1995.66573 1995 [CrossRef]

Matsusue Y.; Hanafusa, S.; Yamamuro, T.; Shikinami Y.; and Ikada Y.: Tissue reaction of bioabsorbable ultra high strength poly (L-lactide) rod. A long-term study in rabbits. Clin. Orthop.,317: 246-253, 1995.317246 1995 [PubMed]

Partio, E. K.; Böstman, O.; Hirvensalo, E.; Vainionpää, S.; Vihtonen, K.; Pätiälä, H.; Törmälä, P.; and Rokkanen, P.: Self-reinforced absorbable screws in the fixation of displaced ankle fractures. A prospective clinical study of 152 patients. J. Orthop. Trauma,6: 209-215, 1992.6209 1992 [PubMed][CrossRef]

Pihlajamäki, H.; Böstman, O.; Hirvensalo, E.; Tömälä, P.; and Rokkanen, P.: Absorbable pins of self-reinforced poly-L-lactic acid for fixation of fractures and osteotomies. J. Bone and Joint Surg.,74-B(6): 853-857, 1992.74-B(6)853 1992

Pihlajamäki, H.; Böstman, O.; and Rokkanen, P.: A biodegradable expansion plug for fixation of the coracoid bone block in the Bristow-Latarjet operation. Internat. Orthop.,18: 66-71, 1994.1866 1994 [CrossRef]

Tegnander, A; Engebretsen, L; Bergh, K; Eide, E.; Holen, K. J.; and Eversen, O. J.: Activation of the complement system and adverse effects of biodegradable pins of polylactic acid (Biofix) in osteochondritis dissecans. Acta Orthop. Scandinavica,65: 472-475, 1994.65472 1994 [CrossRef]

Weiler, A.; Helling, H.-J.; Kirch, U.; Zirbes, T. K.; and Rehm, K. E.: Foreign-body reaction and the course of osteolysis after polyglycolide implants for the fracture fixation. Experimental study in sheep. J. Bone and Joint Surg.,78-B(3): 369-376, 1996.78-B(3)369 1996

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Fig. 1 Anteroposterior radiograph of the left ankle, showing a displaced bimalleolar fracture.

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Barber, F. A.; Elrod, B. F.; McGuire, D. A.; and Paulos, L. E.: Preliminary results of an absorbable interference screw. Arthroscopy,11: 537-548, 1995.11537 1995 [PubMed][CrossRef]

Böstman, O. M.: Current concepts review. Absorbable implants for the fixation of fractures. J. Bone and Joint Surg.,73-A: 148-153, Jan. 1991.73-A148 1991

Bucholz, R. W.; Henry, S.; and Henley, M. B.: Fixation with bioabsorbable screws for the treatment of fractures of the ankle. J. Bone and Joint Surg.,76-A: 319-324, March 1994.76-A319 1994

Hovis, W. D., and Bucholz, R. W.: Polyglycolide bioabsorbable screws in the treatment of ankle fractures. Foot and Ankle Internat.,18: 128-131, 1997.18128 1997

Mainil-Varlet, P.: Polylactic acid pins [letter; comment]. Acta Orthop. Scandinavica,66: 573-574, 1995.66573 1995 [CrossRef]

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OLE M. BÖSTMAN, HARRI K. PIHLAJAMÄKI; Late Foreign-Body Reaction to an Intraosseous Bioabsorbable Polylactic Acid Screw. A Case Report*. The Journal of Bone & Joint Surgery. 1998 Dec;80(12):1791-4.

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