Utilisation des implants biodégradables dans le traitement chirurgical des fractures et au cours des ostéotomies

Résumé L'utilisation de matériaux d'ostéosynthèse biodégradables a l'avantage d'éviter la réintervention pour extraire le matériel. Les biomatériaux de polymères polyglycolides ont été expérimentés sur plus de 3 600 animaux de laboratoire avant leur introduction en pratique clinique. Depuis 1984 nous les avons utilisés comme matériau d'ostéosynthèse dans près de 1 700 cas parmi lesquels 880 cas de fracture malléolaire, 226 cas d'ostéotomie en chevron pour hallux valgus, 65 cas de fracture de la tête radiale et 54 cas de fracture de l'olécrane. Parmi les 800 premiers cas traités par broches biodégradables nous avons obtenu des résultats favorables et sans incidents dans 91 pour cent des cas. Il y eut 7 cas de fixation défaillante nécessitant une réintervention. Il y a eu 7 cas d'infection superficielle et 3 cas d'infection profonde. Nous avons observé la formation d'une collection séreuse sous-cutanée sans influence sur le résultat radiologique ou clinique dans 52 cas (6,5 %). Au vue de ces résultats et compte tenu des avantages économiques et psychologiques des matériaux biodégradables (pas de réintervention), on peut penser que l'usage de biomatériaux rivalise favorablement avec l'usage de matériaux conventionnels dans certains types d'ostéosynthèse.

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Utilization of biodegradable implants in the surgical treatment of fractures and osteotomies

Summary The utilization of biodegradable implants instead of metals in orthopaedic surgery abolishes the need to remove the fixation material. For this study biodegradable rods and screws of self-reinforced polyglycolide, polylactide and lactide-glycolide copolymer were developed and manufactured. The clinical introduction of these implants was preceded by thorough experimental studies with 3 600 animals. From November 1984 the developed biodegradable method of osteofixation was used in 1 700 operations. These included 880 displaced malleolar fractures, 226 chevron-osteotomy for hallux valgus, 65 displaced fracture of the radial head, 54 displaced frature of the olecranon and other fresh fractures or orthopaedic operations. In the first 800 cases operated on using self-reinforced polyglycolide rods the postoperative course was uneventful (91%). Because of failure in the fixation reoperation was needed in 7 cases. A superficial wound infection was observed in 7 cases, deep infection in 3 and transient fluid accumulation in 52 cases (6,5%). Fluid accumulation did not influence the radiological or clinical end-result. The advantages of biodegradable fixation are many-sided. There is a costbenefit and clinical capacity is free for other use, and psychological advantages must be emphasised because removal of implants is not needed. The over all results of this study were considered favourable.

     

Effect of totally absorbable implant volume on wound infection rate: Study of 2500 operated fractures, osteotomies, and ligament injuries

Between November 1984 and January 1994 in our department, a total of 2500 patients were treated with totally absorbable internal fixation devices. We studied these patients and analyzed results with regard to the volume of the absorbable implants and the development of wound infection. Of the 2500 patients 2044 were trauma patients and 456 were operated on for orthopedic disease. In 1466 patients treated with implants made of self-reinforced polyglycolic acid (SR-PGA) only, the patients who developed wound infection had a higher implant volume (P=0.07) than those who did not; this difference was close to statistical significance. In the 446 patients who received only implants made of self-reinforced poly-l-lactic acid (SR-PLLA), the 5 who developed wound infection had a mean implant volume more than three times that of the non-infected patients (P=0.01). We found that in the patients treated with the earlier SR-PGA implants, which contained a green staining material, there was no correlation between implant volume and incidence of wound infections. On the other hand, both the non-stained SR-PGA implants, which have been in clinical use since 1989, and the SR-PLLA implants, seem to be more predictable in terms of wound infections. We believe that this difference, is largely due to the lower level of tissue reactions with these newer implants.     

Immobilisierung und Frühmobilisierung von Malleolarfrakturen nach Osteosynthese mit resorbierbaren Schrauben

71 patients with displaced ankle fracture were treated by using absorbable screws in the fixation of fractures. The follow-up time was 17 (13 to 33) months in average. The fixation devices were SR-PLLA (self-reinforced poly-L-lactide) and SR-PGA (self-reinforced polyglycolide) screws. 38 of the ankle fractures were immobilized with plaster cast and 33 ankle joints were mobilized immediately with a brace. An exact radiological result was achieved in 66 cases, insignificant displacement was observed in four cases and the result was poor in one patient. The result was classified as excellent in 62 patients, as good in eight patients and as poor in one patient. The patients treated postoperatively without plaster healed in a somewhat shorter time, but at one year check-up the differences in the clinical results were almost eliminated. Selected ankle fractures fixed with absorbable screws can be treated postoperatively with early mobilization without plaster.     

Nonoperative approach to endotension

OBJECTIVE: The necessity of operative treatment of endotension after endovascular grafting of abdominal aortic aneurysms (endovascular aneurysm repair; EVAR) is under debate. The proposed causes of endotension and related treatment protocols are controversial. We report the outcome of a nonoperative approach to five patients with endotension after EVAR. METHODS: From February 1997 to August 2004, 160 patients who underwent EVAR of an infrarenal abdominal aortic aneurysm were evaluated for the incidence of endotension. According to the endovascular protocol, plain radiographs, spiral computed tomography, and angiography were performed before and after surgery for follow-up. To detect endotension, spiral computed tomography was performed by using a delayed imaging technique after the infusion of contrast medium. Endotension was defined as an aneurysm sac enlargement after EVAR without evidence of endoleak. Aneurysm sac rupture was defined as discontinuity of the calcific rim of the aneurysmal sac and the presence of intra-aneurysmal fluid outside the sac. RESULTS: We found five (3.1%) patients with endotension. Three of these experienced aneurysmal sac rupture. Only one of the three was underwent operation on experiencing sudden intestinal occlusion due to intra-abdominal adhesions. This patient had no intra-abdominal or retroperitoneal bleeding or hematoma but died after intensive care as a result of non-aneurysm-related problems. Four patients with endotension are still being closely followed up according to our surveillance protocol, and they are doing clinically well. After rupture, clear shrinking of the aneurysm sac was seen in two patients. CONCLUSIONS: Endotension after EVAR may cause subsequent aneurysm rupture. Endotension is evidently not associated with endoleak I to III provided that the endovascular graft is maintained in appropriate position and that free endovascular flow is observed. We propose to consider a nonoperative approach in the clinically asymptomatic patient with aneurysm enlargement after EVAR if endoleak is excluded by well-performed imaging techniques.     

Healing of subcapital femoral osteotomies fixed with self-reinforced poly-L-lactide screws: an experimental long-term study in sheep

Subcapital femoral osteotomies of ten young adult sheep were fixed with two bioabsorbable, self-reinforced, poly- L-lactide (SR-PLLA) lag screws of 4.5 mm in diameter. At 3 weeks radiographs were taken to check the reduction and fixation achieved. After follow-up periods of 12 weeks, 1 year and 3 years with three sheep in each group, and of 7 years and 4 months with one sheep, the sheep were killed, and the healing of the osteotomies, degradation and tissue response of the implants were examined radiographically, histologically and microradiographically. All osteotomies healed with a firm bony union. There was no dislocation or wound infection. Histologically, there was no marked tissue response in the bone tissue. At 12 weeks the implants were grossly intact, at 1 year granulation tissue and new bone formation had started to penetrate into the implant, and at 3 years the implant area was mostly replaced by connective tissue and new bone, but implant material was still seen as little islands surrounded by some lymphocytes. At 7 years and 4 months, the implant material had been degraded and replaced by tight bone. Self-reinforced poly- L-lactide lag screws seem to possess adequate mechanical properties and good biocompatibility for this demanding fixation.     

A long-term clinical study on dislocated ankle fractures fixed with self-reinforced polylevolactide (SR-PLLA) implants

Sixteen patients with dislocated ankle fractures fixed between 1988 and 1991 with self-reinforced poly(L-lactide; SR-PLLA) screws and/or rods were followed up after 8.6 to 11.7 years (mean 9.6 years) at the Department of Orthopaedics and Traumatology, Helsinki University Central Hospital. In all patients accurate reduction of the fractures was retained and uneventful bony union was achieved. Good or excellent long-term functional results were observed in 15 out of 16 patients. One patient had post-traumatic osteoarthritis. In 5 patients, a late tissue reaction was observed over an extruding screw head with mild symptoms, which led to removal of small palpable masses. There were two superficial wound infections, one after a primary operation and one caused by a late tissue reaction after an operation. The correct operative technique, where all extruding extraosseous SR-PLLA material should be removed during the primary operation, should be followed.     

Impact of the use of absorbable fracture fixation implants on consumption of hospital resources and economic costs

Within a 6-year period (1984-1989) absorbable pins, rods, and screws made of polyglycolide, polylactide, or lactide-glycolide copolymer were used in the internal fixation of 881 fractures, 73.1% of which were displaced malleolar fractures of the ankle. During the last 3 years the patients treated using absorbable fracture fixation constituted 19.6% of all fracture patients managed by internal fixation at the department. The number of hardware removal procedures avoided during the 6-year period as a result of the use of the absorbable implants was estimated at approximately 700. By determining all direct and indirect costs associated with internal fracture fixation and the influence of the percentage of hardware removal, a cost coefficient was calculated for certain fracture types when treated using absorbable versus metallic internal fixation. In bimalleolar fractures, an optimal indication for absorbable fixation, the coefficient was 1.04 (cost of absorbable fixation 4% higher than that of metallic fixation) if the removal percentage with metallic fixation was zero and 0.91 (cost of absorbable fixation 9% lower than that of metallic fixation) if the removal percentage was 100%. The breakeven point was a removal rate of 31%.     

Talocrural arthrodesis with absorbable screws, 12 cases followed for 1 year.

In 11 patients, 12 arthrodeses of the ankle joint were performed by using absorbable self-reinforced poly-l-lactide (SR-PLLA) or polyglycolide (SR-PGA) screws. 8 patients had posttraumatic arthrosis, 3 rheumatoid arthritis, and 1 rigid flexion contracture of the ankle due to neuropathy. The average follow-up time was 14 (7-22) months. Solid fusion was achieved in 11 of 12 cases in 9(6-16) weeks.     

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.     

Effect of ultrasound therapy on bone healing of lateral malleolar fractures of the ankle joint fixed with bioabsorbable screws

Background We investigated the effect of low-intensity ultrasound on bone healing in bioabsorbable self-reinforced poly-l-lactic acid (SR-PLLA) screw-fixed lateral malleolar fractures. The study design was prospective, randomized, double-blind, and placebo-controlled.Methods A total of 22 fractures were fixed with one SR-PLLA screw. All the patients were instructed to use an ultrasound device 20 min daily for 42 days without knowing whether it was active or inactive. Eleven patients had active and eleven sham ultrasound devices. The causes of error during treatment with head module placement and attachment to the convex surface of the lateral distal fibula were minimized by careful targeting and using coupling gel. Radiological fracture healing was assessed by radiographs and multidetector computed tomography (CT) scans in a blinded manner by a radiologist and orthopedic surgeons.Results The overall compliance to the daily ultrasound treatments was good. All wounds healed uneventfully, and no foreign body reactions were observed. No difference was observed between the groups regarding either fracture line visualization or callus formation assessed by plain radiographs. In the CT images at 9 weeks, the share of the endosteal united fracture line compared to the non-united fracture line was slightly higher in the active ultrasound device group than in the sham ultrasound device group, but the difference was not statistically significant.Conclusion The study indicates that the biocompatibility of ultrasound therapy and bioabsorbable SR-PLLA screw fixation is good. There was no obvious effect of low-intensity ultrasound on lateral malleolar fracture healing. However, the relatively small number of patients must be kept in mind when interpreting our results. It is also important to limit any conclusions based on the present study to malleolar fractures fixed with the SR-PLLA screw.