Tissue restoration after resorption of polyglycolide and poly-laevo-lactic acid screws.

Despite worldwide clinical use of bio-absorbable devices for internal fixation in orthopaedic surgery, the degradation behaviour and tissue replacement of these implants are not fully understood. In a long-term experimental study, we have determined the patterns of tissue restoration 36 and 54 months after implantation of polyglycolic acid and poly-laevo-lactic acid screws in the distal femur of the rabbit. After 36 months in the polyglycolic acid group the specimens showed no remaining polymer and loose connective tissue occupied 80% of the screw track. Tissue restoration remained poor at 54 months, the amounts of trabecular bone and haematopoietic elements being significantly lower than those in the intact control group. The amount of trabecular bone within the screw track at 54 months in the polyglycolic acid group was less than in the empty drill holes (p = 0.04). In the poly-laevo-lactic acid group, polymeric material was present in abundance after 54 months, occupying 60% of the cross-section of the core area of the screw track. When using absorbable internal fixation implants we should recognise that the degradation of the devices will probably not be accompanied by the restoration of normal trabecular bone.

Clinical biocompatibility of biodegradable orthopaedic implants for internal fixation: a review.

When the polymeric material reaches the final stages of its degradation process, biodegradable orthopaedic fixation devices elicit a local foreign-body reaction. In most cases, the symptoms of this tissue response are subclinical and pass unnoticed, but in some patients a clinically manifest inflammatory foreign-body reaction ensues. Mild clinical reactions consist of a painful erythematous papule, those of medium severity show a sinus discharging polymeric debris for up to 6 months, and in the patients affected by a severe reaction, extensive osteolytic lesions may develop at the implant tracks. The histopathologic picture is that of a non-specific foreign-body reaction. For implants made of polyglycolide, the average incidence of the manifest reactions is 5%. When slow-degrading polymers are used, the incidence is lower. The tissue responses to polyglycolide manifest themselves 11 weeks after surgery, on an average, whereas foreign-body reactions to devices made of poly-L-lactide can emerge as late as 4 or 5 yr after the original fracture fixation operation. A poorly vascularized bone section, use of a quinone dye as an additive in the polymer, and an implant geometry with large surface area each seems to be associated with an increased risk of the occurrence of a foreign-body reaction. Yet in majority of the patients affected, no known individual marker of high risk is present. Some recent laboratory experiments indicate that it may be possible to diminish the risk of an adverse tissue response by incorporating alkaline salts or antibodies to inflammatory mediators in the implants. The results of in vitro and animal experiments, however, cannot always be directly extrapolated to humans. Only large-scale long-term clinical research will ultimately show which physico-chemical characteristics of a biodegradable orthopaedic implant provide the optimal clinical biocompatibility.

In vivo monitoring of the degradation process of bioresorbable polymeric implants using magnetic resonance imaging.

The degradation of a bioresorbable poly(L-lactide) osteosynthesis plug after fixation of a transferred coracoid bone block using the Bristow-Latarjet procedure was examined by means of magnetic resonance (MR) imaging. There were 15 patients with a mean follow-up time of 38 months (range 34-42 months). The gross geometry of the biomaterial plug remained unaltered on the MR images. The bone marrow signal reached the implant surfaces in all cases, and no signs of liquid phase around the implant could be discerned. The implants themselves were visible as homogeneous low signal intensity (SI) black linear structures when compared to the surrounding bone, which had a much higher SI. The mean implant SI was 18.2 (s.d. +/- 6.6), that of the scapular bone 48.9 (s.d. +/- 14.3) and that of the background 4.3 (s.d. +/- 1.5). The SI of a newly manufactured intact implant was 5.7. Serial plain radiographs showed no decreased bone density or focal osteolytic lesions around the poly(L-lactide) expansion plug. The implant channel was discernible on most of the radiographs and a sclerotic rim was detected to outline the implant profile in some of the projections of plain radiographs at each follow-up examination. Computer tomography scans on five patients 3 years postoperatively also revealed a discernible implant channel outlined with a sclerotic rim. The radiographic appearance of the radiolucent implant channel did not change over the follow-up period. Summarizing the present findings, MR imaging seems to be able to visualize poly(L-lactide) implants within the bone. Actually, at present it is the only method available to study the degradation process of implants made of this polymer in humans. No signs of degradation of or of an osteolytic foreign-body reaction to poly(L-lactide) at the host tissue-implant interface could be observed within the follow-up times of this study.

Shear strength of a distal rabbit femur during consolidation of an osteotomy fixed with a polylactide expansion plug.

The consolidation of a transverse transcondylar osteotomy of the distal rabbit femur, fixed with a self-reinforced polylactide expansion plug, was studied radiographically and mechanically. The peak shear force was assessed by stressing the osteotomy site to failure. The intact contralateral femur of the same rabbit served as a control. Fifteen rabbits were tested in groups of five animals with follow-up times of 6, 12 or 24 wk after fixation of the osteotomy. The absorbable plug, measuring 4.5 mm in diameter and 30 mm in length, had an expandable distal locking blade system. Thirteen osteotomies showed a radiographically solid bony union. The mean shear strength of the specimens was 3.5 MPa at 6 wk, 3.5 MPa at 12 wk and 4.3 MPa at 24 wk. The mean shear strength of the control distal femora was 3.6 MPa. In conclusion, the fixation properties of the newly developed absorbable expansion plug were deemed satisfactory in this experimental fracture model.

Bioabsorbable fixation in orthopaedic surgery and traumatology.

Bioabsorbable internal fixation devices were introduced clinically in the treatment of fractures and osteotomies of the extremities at the Department of Orthopaedics and Traumatology, Helsinki University, in 1984. Since November 5, 1984, a total of 3200 patients were managed using bone or ligament fixation devices made of self-reinforced (matrix and fibres of the same polymer) bioabsorbable alpha-hydroxy polyesters. The devices used included cylindrical rods, screws, tacks, plugs, arrows, and wires. The most common indication for the use of bioabsorbable implants was the displaced malleolar fracture of the ankle. Transphyseal fixation with small-diameter, mainly polyglycolide pins was used in children. The postoperative clinical course was uneventful in more than 90% of the patients. The complications included bacterial wound infection in 4% and failure of fixation in 4%. In one-fifth of the latter cases, however, re-operation was not necessary. The occurrence of non-infectious foreign-body reactions two to three months postoperatively has been observed in 2% of the patients operated in the last few years with polyglycolide implants but none of the patients managed with polylactide implants. This inflammatory tissue response often required aspiration with a needle but did not influence the functional or radiologic result of the treatment. Owing to the biodegradability of these internal fixation devices, implant removal procedures were avoided. This results in financial benefits and psychological advantages. Bioabsorbable implants can also be used in open fractures and infection operations.

Restoration of tissue components after insertion of absorbable fracture fixation devices of polyglycolide through the articular surface: an experimental study in the distal rabbit femur.

Absorbable implants for fracture fixation do not require a secondary removal procedure, a fact that could make them particularly suitable for intra-articular fixation, provided the degree of regeneration of the articular surface is acceptable. To determine the restoration pattern in distal rabbit femurs after the intra-articular insertion of absorbable fixation devices, polyglycolide pins and screws were implanted through the articular surface of the intercondylar portion of the bone in adult animals. The polymer was known to have a degradation time of approximately 20 weeks. At follow-up times of 3-48 weeks, the restoration of the tissue components was examined histomorphometrically and microradiographically. The intact contralateral femur served as an internal control. The first signs of degradation of the implants were seen at 6 weeks. The mean fractional osteoid formation surface of the bone trabeculae within the sample fields showed significantly increased values until 6 weeks but thereafter approached the level of the control femur. In the 36-week and 48-week specimens, the polyglycolide had been absorbed and the intra-articular entrance of the implant channel had become filled either with firm whitish tissue resembling mature articular cartilage or with soft undifferentiated mesenchymal tissue only. Good restoration of the trabecular bone architecture corresponding to the original subchondral bone was a prerequisite for the regeneration of the articular cartilage. The causes of the dichotomous pattern of restoration could not be identified, but possibly it represented a normal biologic variation.(ABSTRACT TRUNCATED AT 250 WORDS)

Refracture after removal of a condylar plate from the distal third of the femur.

Of 103 patients who had a fracture of the distal third of the femur that was treated by open reduction and internal fixation with a condylar blade-plate, sixty-two had removal of the plate after the fracture had united. The mean interval between injury and removal of the plate was twenty-six months. Six patients (10 per cent) sustained a refracture that was unrelated to major trauma; the refracture occurred twelve to ninety-three days after removal of the plate. Five of the six refractures occurred through a hole of a supplemental interfragmentary lag-screw. The use of such screws significantly increased the risk of refracture after removal of the hardware (p less than 0.01). The refractures were treated by intramedullary nailing in five patients and by replating in one, and union was achieved in all six patients. Routine removal of a condylar blade-plate after union of a fracture of the distal third of the femur cannot be recommended, especially in the presence of supplemental fixation with interfragmentary screws.

Degradation and tissue replacement of an absorbable polyglycolide screw in the fixation of rabbit femoral osteotomies.

Degradation and tissue replacement of a totally absorbable polyglycolide screw, 4.5 millimeters in diameter and thirty millimeters in length, were studied histologically, morphometrically, and radiographically at sequential stages of resorption at as long as thirty-six weeks after fixation of a transverse distal femoral osteotomy in rabbits. The initial mean shear force to failure was 95.0 newtons for the specimens that had been fixed with the polyglycolide screw compared with 257.0 newtons for the distal part of the contralateral, intact femur. The physical appearance of the screw was unaltered at three weeks. The first histological signs of degradation were seen at six weeks, along the thread ridge. Premature breakage of the screw resulted in gross displacement and non-union of the osteotomy in one animal. The degradation of polyglycolide was accompanied histologically by a typical non-specific foreign-body reaction. This kind of tissue response seemed to be associated with an osteolytic proximal expansion of the implant cavity that was suggestive of increased pressure within the cavity during degradation of the screw. In eight specimens, a wall of new bone formed around this area of osteolysis and demarcated the implant cavity from the surrounding normal cancellous bone. Seventy-four per cent of the periphery and 28 per cent of the central core of the screw had been resorbed at twelve weeks. At thirty-six weeks, no polymeric material could be discerned, and the predominant tissue component within the implant cavity was loose connective tissue. The volume fractions of trabecular bone and hematopoietic bone marrow were significantly lower (p less than 0.01) than those of the intact, control side, but the degree of restoration of tissue varied considerably from animal to animal.

Body mass index and height in patients requiring surgery for lumbar intervertebral disc herniation.

The immediate preoperative body mass index and standing body height of 1128 patients who underwent surgery for lumbar intervertebral disc herniation were compared in a cross-sectional study with the corresponding values obtained from a general population sample. The material was divided into sex- and age-specific subgroups. To delineate possible differences, the 99% confidence intervals for the anthropometric mean values were constructed instead of hypothesis testing. With the exception of the oldest age group, from 50 to 59 years, the patients who underwent surgery for a disc herniation were more obese and taller than the population on average in all other sex- and age-specific subgroups. The major contrast emerged in women aged 20-29 years, in whom the 99% confidence interval for the mean body mass index of the patients undergoing surgery on was 25.1-27.3 kg/m2 versus 22.3-23.1 kg/m2 in the general population. In patients aged 20-39 years the mean body mass index was increased also when the body height of the patients was less than the mean value of the general population samples. Both an increased body mass index and a tall stature seem to have a clear association with those severe lumbar intervertebral disc herniations that require operative treatment.

Blood loss, operating time, and positioning of the patient in lumbar disc surgery.

Many textbooks and papers on lumbar disc surgery still, nearly 40 years after the first description of a variant of the kneeling position, pay no attention to the positioning of the patient. In this study, the association between intraoperative blood loss, operating time, and position of the patient was studied in 436 patients undergoing a standard macrosurgical operation for lumbar disc herniation. Prone position on bolsters was used in 216 cases, 192 of which were primary operations, and a frame-supported kneeling position in 220, 203 of which were primary operations. The mean blood losses in prone versus kneeling positions in the primary operations were 376 ml and 150 ml, respectively (P less than 0.001), and the mean operating times were 74 minutes and 52 minutes, respectively (P less than 0.001). The 99% confidence interval for the difference between the mean operating times was from 15 to 29 minutes. A moderate nonlinear positive correlation was found between intraoperative blood loss and operating time. No intraoperative complications attributable to the position of the patient emerged. On the basis of the findings in this study, the use of kneeling position is strongly advocated.

Reduction of bone retropulsed into the spinal canal in thoracolumbar vertebral body compression burst fractures. A prospective randomized comparative study between Harrington rods and two transpedicular devices.

STUDY DESIGN: This was a prospective, randomized study. OBJECTIVE: To compare the ability of three methods of internal fixation (Harrington rods, AO internal fixator, posterior segmental fixator) to obtain reduction of intracanal fragments in thoracolumbar vertebral compression burst fractures. SUMMARY OF BACKGROUND DATA: Sixty-seven acute thoracolumbar compression burst fractures of T12 or L1 were randomized into three groups that were treated using one of the three methods. Reduction was accomplished indirectly by distraction applied using the fixation device. METHODS: The spinal canal encroachment was calculated as a percentage of the estimated pre-injury value from serial transverse computed tomographic scans obtained on admission and immediately after surgery. RESULTS: The median preoperative sagittal encroachment of the spinal canal was 37% (range, 0-90%) of the normal diameter. All three methods of internal fixation produced a spinal canal clearance provided that the patient was operated on within 4 days after trauma. The median postoperative encroachment varied from 13% (range, 0-37%) to 22% (range, 0-37%), the best reduction being attained using Harrington rods and the poorest with the posterior segmental fixator. There was a suggestive statistical significance between these two. CONCLUSION: The differences in postoperative spinal canal encroachment and ability to obtain spinal canal clearance observed between the devices studied were small. There seems to be no reason to base the choice of the operative method in thoracolumbar fractures on any hypothetical differences in reductive power between Harrington rods and the AO internal fixator.

Magnetic resonance imaging during healing of surgically repaired Achilles tendon ruptures.

Twenty consecutive patients with 21 surgically repaired Achilles tendon ruptures were imaged with a 0.1-T magnet at 3 and 6 weeks, and at 3 and 6 months after surgery. Clinical follow-up examinations and functional tests were performed at the time of scanning. An intratendinous area of high-intensity signal was observed in 19 of the 21 surgically repaired Achilles tendons at 3 months after surgery on proton density- and T2-weighted images. The three patients with the largest lesions had clinically poor outcomes at 3 months, whereas those with smaller intratendinous lesions had normal recoveries. Furthermore, patients with an abnormal walk at 3 months (N = 5) had statistically larger intratendinous lesions than patients who could walk normally. In all patients the cross-sectional area of the rejoined Achilles tendon showed the largest increase after cast removal (between 6 weeks and 3 months after surgery). In all cases the largest tendon area was measured at 3 months after surgery. Magnetic resonance imaging provides a precise valuable tool to evaluate the postsurgical internal structure of the surgically repaired Achilles tendon.

Osteolytic changes accompanying degradation of absorbable fracture fixation implants.

We analysed the radiographs of 67 patients with displaced malleolar fractures treated by open reduction and internal fixation using absorbable polyglycolide rods. Seventeen patients developed a discharging inflammatory foreign-body reaction, a complication unique to these fixation devices. In 34 patients ovoid osteolytic foci, usually 5 to 10 mm in diameter, appeared within the implant channels six to 12 weeks after the operation. The same lesion occurred in 14 of the 17 patients who developed a foreign-body reaction, whereas only 20 out of the 50 patients with an uneventful course showed osteolytic areas (p less than 0.01). In patients with a foreign-body reaction the osteolytic foci tended to occur in the deepest parts of the implant channels. However, after one year the normal structure of the bone was restored.

Body-weight related to loss of reduction of fractures of the distal tibia and ankle.

A series of 3061 patients with fracture of the distal tibia or ankle was studied for a possible link between overweight and failed reduction. The relative body-weight was recorded as the preoperative self-reported body mass index (BMI) of each patient. There were 109 patients (3.6%) with failure of internal fixation or of closed reduction severe enough to necessitate refixation or corrective osteotomy. The mean BMI in all age- and gender-specific groups studied was found to be significantly higher in patients with failed reduction than in those with an uneventful course (p < 0.01). The relative risk of loss of reduction for patients with a BMI greater than 1SD above the BMI of the corresponding age and gender group of the general population was 3.72 for distal tibial fractures and 3.04 for ankle fractures. Overweight should be recognised as a significant factor in predicting a complicated course after a fracture of the lower leg. Awareness of the increased risk of loss of reduction in overweight patients is important in all phases of management.

Osteoarthritis of the ankle after foreign-body reaction to absorbable pins and screws: a three- to nine-year follow-up study.

Between 1985 and 1994, 1223 patients with malleolar fractures of the ankle were treated by open reduction and internal fixation with absorbable pins and screws, of whom 74 (6.1%) had an obvious inflammatory foreign-body reaction to the implants. Of these 74, ten later developed moderate to severe osteoarthritis of the ankle despite no evidence of incongruity of the articular surface. The implants used in these patients were made from polyglycolide, polylactide or glycolide-lactide copolymer. The joint damage seemed to be due to polymeric debris entering the articular cavity through an osteolytic extension of an implant track. The ten patients had a long clinical course which included a vigorous local foreign-body reaction, synovial irritation and subsequent degeneration. At a follow-up of three to nine years, ankle arthrodesis had been necessary in two patients and is being considered for another two. The incidence of these changes in the whole series was 0.8%, which is not high, but awareness of this possible late complication is essential.

Spiral fractures of the shaft of the tibia. Initial displacement and stability of reduction.

We have analysed the initial displacement and the retention of position after reduction of 192 spiral fractures of the tibial shaft. In fractures with an initial lateral displacement of one half the width of the shaft or more, successful retention of position after the primary closed reduction was achieved in only 18%. The direction of displacement between the tibial fragments showed little variation; the proximal fragment was always medial and anterior to the distal. This resulted in an increased space between the proximal tibial fragment and the shaft of the fibula in the plane of the interosseous membrane. There was a strong correlation between the initial displacement and the initial shortening. No evidence of a posterior soft-tissue hinge, able to facilitate closed reduction, could be found. Consequently, in treating severely displaced spiral fractures, open reduction and internal fixation or a few weeks' initial calcaneal traction seem to be the rational alternatives.

Complications of transpedicular lumbosacral fixation for non-traumatic disorders.

We analysed the complications encountered in 102 consecutive patients who had posterolateral lumbosacral fusion performed with transpedicular screw and rod fixation for non-traumatic disorders after a minimum of two years. Of these, 40 had spondylolysis and spondylolisthesis, 42 a degenerative disorder, 14 instability after previous laminectomy and decompression, and six pain after nonunion of previous attempts at spinal fusion without internal fixation. There were 75 multilevel and 27 single-level fusions. There were 76 individual complications in 48 patients, and none in the other 54. The complications seen were screw misplacement, coupling failure of the device, wound infection, nonunion, permanent neural injury, and loosening, bending and breakage of screws. Screw breakage or loosening was more common in patients with multilevel fusions (p < 0.001). Screws of 5 mm diameter should not be used for sacral fixation. Forty-six patients had at least one further operation for one or several complications, including 20 fusion procedures for nonunion. The high incidence of complications is a disadvantage of this technically-demanding method.

Foreign-body reactions to fracture fixation implants of biodegradable synthetic polymers.

Biodegradable rods of polyglycolide or lactide-glycolide copolymer were used in the internal fixation of a variety of fractures and osteotomies in 516 patients. A clinically manifest foreign-body reaction occurred in 41 patients (7.9%), producing a fluctuant swelling at the implantation site after an average of 12 weeks. Spontaneous sinus formation or surgical drainage yielded a sterile exudate containing liquid remnants of the degrading implants. After prompt drainage this discharge subsided within three weeks. Histological examination showed a typical nonspecific foreign-body reaction with abundant giant cells both in patients with the reaction and in some patients with an uneventful clinical course. The factors determining the nature of the reaction were probably related to the local capacity of the tissues to clear the polymeric debris. The reactions did not influence the clinical or radiographic results, but recognition of the incidence and the features of the reaction is necessary in view of the increasing use of such implants.

Anterolateral decompression for neural involvement in thoracolumbar fractures. A review of 78 cases.

Of a total of 905 patients with fracture or fracture-dislocation of the thoracolumbar spine admitted from 1969 to 1982, a neurological deficit was present in 334 (37%). All unstable injuries were initially treated by reduction and posterior fusion. In 79 of these patients, an anterolateral decompression was undertaken later because of persistent neurological deficit and radiographic demonstration of encroachment on the spinal canal. One patient died of pulmonary embolism; 78 were reviewed after a mean period of four years. Of these 78 patients 18 made a complete neurological recovery while 53 appeared to have benefited from the procedure; 25 remained unchanged. The best results were obtained in burst fractures at thoracolumbar and lumbar levels when a solitary detached fragment of a vertebral body had been displaced into the spinal canal. These results indicate that anterolateral decompression of the spinal canal should be considered, after careful evaluation, for certain injuries of the spine in which there is severe neural involvement.

Failure of reduction with an external fixator in the management of injuries of the pelvic ring. Long-term evaluation of 110 patients.

We reviewed 110 patients with an unstable fracture of the pelvic ring who had been treated with a trapezoidal external fixator after a mean follow-up of 4.1 years. There were eight open-book (type B1, B3-1) injuries, 62 lateral compression (type B2, B3-2) and 40 rotationally and vertically unstable (type C1-C3) injuries. The rate of complications was high with loss of reduction in 57%, malunion in 58%, nonunion in 5%, infection at the pin site in 24%, loosening of the pins in 2%, injury to the lateral femoral cutaneous nerve in 2%, and pressure sores in 3%. The external fixator failed to give and maintain a proper reduction in six of the eight open-book injuries, in 20 of the 62 lateral compression injuries, and in 38 of the 40 type-C injuries. Poor functional results were usually associated with failure of reduction and an unsatisfactory radiological appearance. In type-C injuries more than 10 mm of residual vertical displacement of the injury to the posterior pelvic ring was significantly related to poor outcome. In 14 patients in this unsatisfactory group poor functional results were also affected by associated nerve injuries. In lateral compression injuries the degree of displacement of fractures of the pubic rami caused by internal rotation of the hemipelvis was an important prognostic factor. External fixation may be useful in the acute phase of resuscitation but it is of limited value in the definitive treatment of an unstable type-C injury and in type-B open-book injuries. It is usually unnecessary in minimally displaced lateral compression injuries.