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Absorbable implants made of synthetic biodegradable polymers were recently used clinically especially for the fixation of small intra-articular fractures and physical fractures. In the paper history research and current concepts concerning biological response to biodegradable polymers and main indications for using absorbable implants for fixation of fractures are presented.
A total of 1202 fractures of the ankle were treated with absorbable implants made of polyglycolide/polylactide copolymer or self-reinforced polyglycolide and/or self-reinforced polylactide between November 5, 1984, and January 12, 1994. A redisplacement after fixation was diagnosed in 30 patients (2.5%). The redisplacement occurred in 8 of 934 (0.9%) simple ankle fractures and in 22 of 268 (8.2%) severer ankle fractures. A breakage or loosening of the absorbable implant was verified at reoperation in 8 cases and was suspected in another 9. A technical failure was the main reason in 13 cases. A reoperation was performed for 25 patients. The absorbable implants seem to provide a secure fixation in the majority of ankle fractures, but the use of these implants showed unsatisfactory results in unstable and comminuted fractures.
The assimilation characteristics of absorbable bovine fibrin implants in an experimental situation are described, and the effect of delaying absorption with formaldehyde treatment is demonstrated. Essentially, in vivo in the rat, Biethium fibrin implants are absorbed in approximately four to eight weeks because of the polymorphonuclear leukocyte digestion. An indication of the clinical uses in stress incontinence and hemorrhage of the liver are given, together with a look at the future of some of the other areas in which this absorbable, biologic plastic may fit into the surgeon's armamentarium to replace deficient or destroyed tissue.
The mechanical rigidity of five different methods of pin fixation in two proximal phalangeal fracture models was studied and absorbable implants were compared with metallic implants in a biomechanical cadaver study. Thirty phalanges were tested in apex palmar bending, compression and torsion. Results showed that rigidity of absorbable implants was comparable with metallic implants, except in torsion.
Our experience in 1,700 consecutive cases of retinal surgery for the repair of nontraumatic, rhegmatogenous retinal detachments using a modified technique involving a nondrainage procedure with an absorbable implant was presented. We found that 228 of these 1,700 cases fell into our criteria for the use of this technique. We discussed the indications and contraindications for both the operative procedure and for the absorbable implant, and it is our belief that this technique is a valuable addition to the methods available to the retinal surgeon for the treatment of certain selected cases of retinal detachment.
Between 1986 and 1994, 57 consecutive patients with a distal humeral fracture were treated operatively using absorbable implants, 15 of them were treated by combining absorbable pins or screws with metallic implants. According to the AO/ASIF system, there were 13 Type A, 21 Type B and 10 Type C fractures. Thirteen patients were lost to follow-up. The clinical outcome was reviewed in 44 patients with an average follow-up time of 4.6 years. The functional results by Broberg and Morrey were excellent or good in 36 (81%), fair in three (6,8%) and poor in five (11,2%) patients. Twenty-nine (66%) patients indicated their satisfaction with the outcome of the treatment. The elderly had more severely unstable fractures and more unfavourable results than younger patients. A postoperative redisplacement was seen in 11 (25%) patients and infection in seven (16%) patients. An abacterial foreign-body reaction occurred in four (9,1%) patients. The results were favourable in the noncomminuted epicondylar and condylar fractures of the distal humerus as well as in the humeral capitellum fractures. The results were unsatisfactory in the comminuted intraaticular distal humeral fractures.
The aim of this study was to compare the clinical and radiographic results in patients with recurrent unidirectional, post-traumatic shoulder instability (dislocations/subluxations). All the patients had a Bankart lesion and underwent reconstruction using either an open or an arthroscopic technique and absorbable implants. Thirty-three consecutive patients (36 shoulders) were operated on by one surgeon. Group A comprised 18 shoulders which underwent an open Bankart reconstruction using absorbable 3.7-mm TAG suture anchors. Group B comprised 18 shoulders which underwent a combination of an intra- and extra-articular arthroscopic stabilization using 8-mm Suretac fixators. The median number of dislocations before the reconstruction was 5(0-45) in group A and 4 (0-30) in group B (NS). The follow-up examination was performed by an independent observer after a median of 31 (range 25-38) months in group A and 28 (range 18-46) months in group B (NS). An independent radiologist without any knowledge of the surgical procedure evaluated all the radiographs. There were no re-dislocations in either group. In group A, the Rowe and Constant scores were 86 (range 61-98) and 89 (range 73-99), respectively. The corresponding values in group B were 92 (range 83-98; P = 0.05) and 96 (range 75-100; NS). The external rotation in abduction was 65 degrees (range 20 degrees-90 degrees) in group A and 83 degrees (range 65 degrees-105 degrees) in group B (P = 0.0017). The radiographs revealed that 10/18 (56%) in group A and 4/18 (23%) in group B had visible drill-holes or cystic formations in conjunction with the drill-holes (P = 0.002). In this study the open procedure resulted in a restriction in external rotation more frequently than the arthroscopic procedure. The radiographs revealed visible drill-holes or cystic formations in conjunction with the drill-holes more frequently when TAG suture anchors were used than when Suretac fixators were used. The radiographic changes did, not appear to affect the clinical outcome, however.
PATIENTS AND METHODS: Eighteen consecutive patients who had recurrent, unidirectional, post-traumatic shoulder instability were included. All the patients underwent surgery with a standardized open Bankart technique involving absorbable suture anchors. CLINICAL RESULTS: No redislocations occurred during the study period of 31 months (range 25 to 38 months). The Rowe and Constant scores were 86 points (range 61 to 98 points) and 89 points (range 73 to 99 points), respectively. The strength measurements revealed 8.6 kg (range 3.8 to 15 kg) in 90 degrees abduction compared with 9.3 kg (range 2.2 to 16.5 kg) in the control shoulders (not significant). The external rotation in abduction was 65 degrees (range 20 degrees to 90 degrees) compared with 91 degrees (range 80 degrees to 105 degrees) in the control group (P < .001). RADIOGRAPHIC RESULTS: Signs of minor or moderate degeneration were found in 10 of 18 patients on the preoperative radiographs, in 15 of 18 at 7 months, and in 16 of 18 at 33 months (P < .05 before surgery vs 33 months). From the preoperative examination to the 7-month control, 7 of 18 patients had an increase in degenerative changes, and from the 7-month to the 33-month control, an increase was found in 8 of 18 (P = .008, before surgery vs 7 months; P = .005, 7 months vs 33 months). At the 7-month control, 8 of 18 patients had invisible or hardly visible drill holes, and 10 of 18 had visible or cystic drill holes at the site of implantation for the absorbable suture anchors. At the 33-month control, 10 of 18 patients had invisible or hardly visible drill holes, and 8 of 18 had visible or cystic drill holes (not significant, 7 months vs 33 months). CONCLUSION: The method resulted in stable shoulders in 17 of 18 patients. Degenerative changes were present on the radiographs in most of the patients and appeared to increase over time. Visible drill holes or drill holes with cystic changes were seen on the radiographs in a significant number of patients at the 7-month and the 33-month control and did not appear to heal during the follow-up period.
Absorbable fracture fixation has been in clinical use since 1984. Our study compares the infection rates and some infection parameters between metallic (2073 patients) and absorbable fracture fixation devices (1012 patients) in displaced ankle fractures. The infection rate associated with metallic fixation was 4.1%, compared with 3.2% absorbable fixation (p 0.3). The patients who had a wound infection were older when metallic fixation was used (p 0.01). They also had a bi- or trimalleolar fracture more often than did patients treated with absorbable fracture fixation, but this difference did not have a significant effect on the wound infection rate (p 0.2). The infections were mostly caused by microorganisms of the Staphylococcus species. Deep infections were equally common with both fixation methods (0.4%), but there was some variation in the bacterial spectrum.
Three patients (3.8%) of 80 with displaced malleolar fractures treated by open reduction and internal fixation using absorbable polyglycolide rods were found to have developed distal tibiofibular synostosis. To assess the general incidence of this complication, the serial radiographs of 150 patients with an identical distribution of the initial fracture severity treated with AO-ASIF implants were examined for comparison. Among these, no cases of tibiofibular synostosis were found. The difference (P = .04) in incidence was postulated to be due to an osteogenic potential of the absorbable polymeric material, suggested previously in experimental studies. This study included fractures of the lateral malleolus and bimalleolar fractures, but patients with a disruption of the inferior tibiofibular syndesmosis causing tibiofibular diastasis on admission were excluded. The synostoses occurred in middle-aged, sedentary people, and no active measures were necessary because of the mild subjective symptoms of these patients. Previously, posttraumatic distal tibiofibular synostosis has been recorded as an uncommon late complication of severe ankle fractures with tibiofibular diastasis requiring transsyndesmotic fixation, but it has not been reported to occur after malleolar fractures of the kind surveyed in this study.
The authors present two case studies which describe a destructive, nonspecific foreign-body reaction encountered while using the Biofix absorbable rod system. At Dallas Family Hospital, the Biofix system has been used in 32 first metatarsal procedures, 10 lesser metatarsal procedures, and 15 digital procedures. Twenty-seven patients are included, with two developing a reaction that required surgical drainage and debridement. The first reaction was noted to be extremely violent with destruction of bone and soft tissue. Prompt diagnosis and aggressive therapy is necessary to minimize the soft tissue and bony destruction that may occur. Surgical drainage and debridement are often necessary to control the reaction.
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Calcium phosphate fibers designed for reinforcement of bioabsorbable fracture fixation devices were evaluated for their properties upon annealing. The composition of these fibers were 54% PO4, 27% Ca, 12% ZnO, 2.5% NaPO3, and 4.5% Fe2O3, and they were either not annealed, annealed at 250 degrees C, or annealed at 420 degrees C. Chemical degradation, mass loss, and morphology upon degradation were studied. Chemical degradation was performed in Tris-buffered HCl, while mass loss and morphologic studies were performed in both physiologic and nonphysiologic solutions. The results showed that degradation rates for fibers were inversely proportional to the annealing temperature. Mass loss analysis of fibers immersed in the two physiologic solutions (calf serum and simulated body fluid) revealed little change in fiber diameter up to 60 days. Morphologic examination revealed little change in fibers immersed in the two physiologic solutions until 60 days, after which thin shells were found to be peeling off the outer coating of the fiber. Samples in tris-buffered HCl revealed a dramatic difference in mode of degradation among the three fibers. Fibers not annealed and those annealed at lower temperatures underwent a delaminating type of degradation that appeared to destroy the overall integrity of the fiber, whereas fibers annealed at 420 degrees C underwent crater-like deterioration in which the overall alignment of the fiber remained intact. It is therefore concluded that annealing fibers at higher temperatures also undergo a mode of degradation that allows them to maintain their structural integrity. Although annealing fibers close to glass transition temperature may produce an initially weaker fiber, chemical and physical degradation occur much slower, making these fibers most suitable for reinforcement of biodegradable implants.
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Authors report on one case of malleolar synthesis with the use of biodegradable implants. The advantages of the resorbing osteosynthesis materials and the possible complications are described.