Soft tissue reactions of different biodegradable polylactide implants.

Soft tissue reactions resulting from biodegradable polylactide implants to bone have not been adequately examined during their 3-year degradation period. An osteotomy was performed on the medial femoral condyle of 36 sheep and secured by either three poly-L-DL-lactide pins (70/30) (Polypin) or three composite pins [10% beta-tricalcium phosphate (beta-TCP) (90/10)]. A histological examination was performed on the synovial membrane and lymph nodes after 3, 18 and 36 months. After 18 months two non-specific, minor reactions of the synovial membrane were observed in the composite pin group. In both groups different reactions of both inguinal lymph nodes were observed. These had no statistical relevance and could not be clearly attributed to the implants. Due to the slow degradation process of biodegradable polylactide implants, there is no clinically relevant inflammation of either joint or lymph nodes. The addition of 10% beta-TCP did not result in any significant enhancement.

Ultrastructural changes in the dog liver cell after isolated liver perfusion with various cytotoxins.

Following isolated liver perfusion with different cytotoxins - 5-fluorouracil (5-FU), methotrexate (MTX), dacarbazine (DTIC) cis-platinum (cis-PT) - liver tissue of dogs was examined with the electron microscope (a) directly after the perfusion and (b) after a survival time of 4 weeks (5-FU and DTIC). Acute disintegration of the granular endoplasmic reticulum and depletion of the glycogen stores occurred after perfusion with 5-FU, MTX, and DTIC, while cis-PT induced disintegration of the granular endoplasmic reticulum accompanied by an accumulation of glycogen. Four weeks after perfusion with DTIC signs of remarkably increased cellular activity were observed, while 4 weeks after perfusion with 5-FU the parenchymal liver cells revealed a well-balanced and moderate recovery of the cellular structures.

Foreign-body reaction and the course of osteolysis after polyglycolide implants for fracture fixation: experimental study in sheep.

Foreign-body reaction to polyglycolide (PGA) implants has been described in man. Many animal experiments have verified the mechanical properties of fixation devices made from PGA, but a significant foreign-body reaction has not been described. We studied the effect of PGA rods in 12 sheep with standardised osteochondral fractures of the medial femoral condyle fixed with uncoloured, self-reinforced PGA rods (Biofix). Radiographs were taken at intervals ranging from two weeks to two years, and the sheep were killed at intervals ranging from six to 24 months. All knees were examined histologically. Eleven of the 12 fractures healed radiologically and histologically. Moderate to severe osteolysis was seen at four to six weeks with maximum changes at 12 weeks in ten animals. Six knees showed fistula-like connections between the implant site and the joint space. Three developed synovitis, one with inflammatory changes involving the whole cartilage and one with destruction of the medial condyle. Although in our study osteochondral fractures fixed with PGA rods healed reliably, there were frequent, significant foreign-body reactions. Caution is needed when considering the use of PGA fixation devices in vulnerable regions such as the knee.

Right sternoclavicular dislocation after traumatic delivery: a case report.

Sternoclavicular (SC) dislocation is an injury that is very rare in the newborn. Thus far there have been no reports describing this in neonates after a traumatic birth injury. This condition can be difficult to differentiate from epiphyseal separation, which occurs more often in older children. For successful treatment, early diagnosis is essential. Timely surgical reposition and fixation with following immobilization is recommended in instances of complete (SC) dislocation. We report a trauma-induced case of SC dislocation in a neonate successfully managed by polydioxanon cord fixation.

The injury of the calcaneocuboid ligaments.

The selective rupture of the calcaneocuboid ligament is extremely rare and frequently misdiagnosed. This study tries to clarify the mechanism, classification and treatment of this entity. The necessity of radiographs with varus stress and in certain cases of computer tomography (CT) and magnetic resonance imaging (MRI), beside the routine antero-posterior and lateral views, is emphasized. Thirteen cases out of five-hundred-twenty-one sprain injuries of the ankle are described, classified and the therapy discussed: If on varus stress radiographs, there is a calcaneocuboid angle <10 degrees without a bony flake (type 1) strapping for six weeks is indicated. A calcaneocuboid angle >10 degrees with or without a small bony flake of the ligament insertion (type 2) should primarily be treated with a shoe cast for 6 weeks; if there are persistent symptoms a secondary peroneus brevis tendon graft is recommended. A calcaneocuboid angle >10 degrees with a big flake (type 3) should be treated by open reduction and refixation of the ligament. Complex injuries (type 4) are characterised by cuboid compression fracture and ligament rupture.

[Categories for evaluating surgical procedures by expert medical witnesses]. / Kategorien zur gutachterlichen Bewertung chirurgischer Massnahmen.

An analytical procedure is presented that helps to determine the causes of surgical malpractice. A first evaluation scale of six levels is applied to the assessment of the indications for surgery and the method used as well as a second scale for the technical realisation of the treatment. For the indication and method categories A-F are used.A: method of choice; B: a time-tested method but second choice; C: exceptional method, rarely practised; D: historical method no longer in use; E: incorrect method/simple mistake; F: blatant mistake in the assessment of indication or choice of method, not understandable. To evaluate the technical realisation of treatment a scale from 1 to 6 is applied. 1: excellent realisation; 2: successful, but minor drawbacks; 3: atypical but acceptable result; 4: technically failed but no harm to the patient; 5: insufficient realisation; 6: faulty, grossly failed. Three cases are given as examples. In these cases the use of the proposed categories and scaling leads to differentiated assessments.

[New biodegradable polylactide implants (Polypin-C) in therapy for radial head fractures]. / Neue biodegradable Polylactid-implantate (Polypin((R))-C) zur Therapie von Radiuskopffrakturen.

Dislocated radial head fractures of the type Mason II are usually treated with screws and buttress plates. The implants are generally removed at a later date. Biodegradable implants can be applied successfully for the reduction of small radial head fractures subject to shearing forces and slight loads. The implants are completely absorbed once the fracture has healed, making a second operation for the removal of the implant unnecessary. The Polypin C-Pin is made of poly(L, DL-lactide) mixed with 10% beta-tricalcium phosphate to ensure controlled, slow degradation with no significant side effects. This new Polypin C fixation pin was clinically tested on 35 patients with radial head fractures (CCF 21B2.1 and 21B2.2) from 31.10.1996 until 1.4.2002. A total of 34 of the patients (97.1%) underwent a clinical and conventional radiological follow-up examination after an average of 38.2 months. In 29 cases a CT was also carried out. Between 18 and 24 months, two cases of grade 1 osteolysis were observed around the pin head. No trace of osteolysis was observed at the final examination in either case. According to the Broberg score, an average of 96 out of a possible 100 points were attained at the final examination (31 excellent, 2 good, 1 unsatisfactory). After a period of 24 months, the pins were no longer visible on a conventional x-ray. A CT evaluation showed a density similar to that of spongioid bone in the original pin cavities after 3 years. These excellent clinical results prove that the Polypin C is a good method to treat dislocated radial head fractures.

New developments in the application of biodegradable implants.

The application of biodegradable implants is combined with advantages and disadvan- tages. They offer a great deal of innovative ideas. Best evaluation has been done with pins for the fixation of low loaded osteochondral fractures. When using 2,7 mm Polypin® primary mechanical stabilility of distal radius fractures is comparable with the fixation by 1,8 mm K-wires. A prospective and randomised study with two years follow up, including 183 radial head fractures, showed no significant difference in results and complications in metal and polyactide implants. For this localisation and other comparable indications the implant can be recommended. Despite the more extensive degradable device overall costs can be reduced with the polymer implant. Orien- truded polyactide screws showed good clinical results, newetheless resorption was extremely late within 5 to 7 years.

[Treatment of metacarpal fractures]. / Behandlungsmassnahmen bei Mittelhandfrakturen.

Conservative treatment of metacarpal fractures is recommended if there is no joint displacement, malrotation, displacement of over 30 degrees ad axim and shortening of over 5 mm. Surgery should be performed in open fractures and serial fractures of metacarpal bone. Early functional treatment should be carried out in stable, not displaced fractures. A cast can be used for a short period in full extended position of fingers and flexion in metacarpo-phalangeal joint in 60 - 90 degrees. Twin-tape fixation allows functional treatment after soft-tissue swelling has disappeared. Closed reduction of displaced fractures of the fifth metacarpal bone (boxer's fracture) is not successful. Cases with displacement of over 30 degrees may be treated surgically by intramedullary stabilisation.

[Report of the Biodegradable Implants Study Group]. / Bericht der Arbeitsgruppe Biodegradable Implantate.

There is a group for the development and testing of biodegradable implants within the German Section of AO/ASIF-International. After in-vitro screening of various polylactide materials and copolymers a L/DL-polylactide 70/30 was selected. In animal experiments it showed long durability over a period of 9 months and expected degradation afterwards. In clinical experience over more than three years the biodegradable pins with x-ray opaque markers (Polypin) applied for fixation of osteochondral lesions yielded good results and no infections. A multicenter clinical study now includes 57 patients. Polypin is the first biodegradable implant of the AO/ASIF-group.

[New developments in the application of resorbable implants]. / Neue Entwicklungen beim Einsatz resorbierbarer Implantate.

The application of biodegradable implants is combined with advantages and disadvantages. They offer a great deal of innovative ideas. Best evaluation has been done with pins for the fixation of low loaded osteochondral fractures. When using 2.7 mm Polypin primary mechanical stability of distal radius fractures is comparable with the fixation by 1.8 mm K-wires. A prospective and randomised study with two years follow up, including 183 radial head fractures, showed no significant difference in results and complications in metal and polyactide implants. For this localisation and other comparable indications the implant can be recommended. Despite the more extensive degradable device overall costs can be reduced with the polymer implant. Orientruded polyactide screws showed good clinical results, newetheless resorption was extremely late within 5 to 7 years.

Post-traumatic costochondritis caused by Candida albicans. Aetiology, diagnosis and treatment.

Candida costochondritis is a rare disease of complex aetiology. Pathogenetic factors range from postoperative and posttraumatic complications to haematogenous dissemination in intravenous drug addicts. In addition to clinical examination, possible diagnostic procedures include scintiscan and magnetic resonance imaging. The treatment of choice is extensive debridement and resection of the structures affected by the inflammatory process. The long-term prognosis is good.

[Palmar lunate dislocation]. / Palmare Luxation des Os lunatum.

UNLABELLED: Palmar lunate dislocation as the end stage of a perilunate dislocation is a very uncommon injury. Having treated 19,534 hospitalized patients between 1 January 1986 and 1 October 2001 the diagnosis was recorded in four male trauma patients (33, 36, 37 and 62 years old). Among the operatively treated carpal dislocations and carpal fracture dislocations those of the lunate were seen in five per cent. The dislocation was caused in by an acute hyperextension injury resulting of falls from heights in three cases, and of a motorcycle accident in a further case. In two of these cases a complete palmar lunate dislocation was analysed that were produced by fall from seven meters heights of a young craftsman and by accident of a motorcyclist. First using a longitudinal palmar approach in both cases a revision of the hemorrhagic carpal canal was performed urgently, the largely denuded lunate was reduced and the repair of identified ligamentous structures was performed by means of sutures respectively suture anchors. Reduction was stabilized with Kirschner wires. Afterwards performed computed tomography identified the result of reduction and associated defects (subluxation distal radioulnar joint). In one patient a soft tissue infection prevented the dorsal ligamentous repair. In spite of a consequent after-treatment and a good functional result a scapho-lunate dissociation was proved. An avascular defect of the lunate could be excluded by magnetic resonance imaging. In case of a secondary performed dorsal repair a persisting carpal stabilization with a satisfactory functional result could achieved. At second hand an advanced carpal collapse was proved. CONCLUSIONS: If reduction cannot be achieved by closed manipulation or a loss of reduction is shown, open reduction is indicated first by a palmar approach. An additional dorsal ligamentous repair seems to be necessary. Transfixation by Kirschner wires and suture anchors stabilize the restored anatomic relationships. Wrist immobilization in a cast for at least eight weeks is recommended. Although ligamentous insufficiency, osteoarthrosis and avascular necrosis are often proved, functional results are satisfactory.

[A condylar plate in distal femoral fractures]. / Die Kondylenplatte bei distalen Femurfrakturen.

Up to the seventies, the surgical treatment of supra- and bicondylar femoral fractures was difficult and was accompanied by a lot of complications. In most studies conservative treatment was recommended. In the last 30 years the clinical outcome after surgical treatment has improved. This was a result of the development of new implants and improved surgical techniques. Today, the primary surgical treatment is the therapy of choice. We reviewed from 1986 to 2000 105 distal femoral fractures which in 32 cases were treated with a condylar blade plate. The final results were rated using the system that was described by Neer. The averaged follow up time was 9 years. Low postoperative infection rates and in 75% excellent and satisfactory results combined with low cost are the state of art which has to be the reference for new methods and new implants in the future.

[Candida infection in hip alloarthroplasty]. / Candidainfektion nach Alloarthroplastik der Hüfte.

A 46-year-old polytoxicomanic patient underwent a total hip replacement for necrosis of the femoral head. The patient suffered additionally from chronic pancreatitis with insulin-dependent diabetes and polyneuropathy. Three weeks later he developed a deep wound infection followed by surgical revision. The infection persisted despite further revision operations and systemically and locally applied antibiotics. After removal of the prosthesis,microbiology revealed Staphylococcus aureus, enterococcus,and Candida parapsilosis. Five additional revision operations, application of suction-irrigation drainage, and systemically administered antibiotics could not stop the infectious process. The patient was transferred to our institution 3 months after primary surgery. The joint defect was filled with a PMMA Palacos spacer. This time biopsies were only positive for Candida albicans. After 12 days of antifungal therapy with fluconazole,microbiological biopsies were sterile. The spacer was removed and femoral extension applied. After 4 weeks of further antifungal therapy, a revision prosthesis was implanted. Until now no signs of infection have appeared.

[Tossy III injuries of the acromioclavicular joint. In what circumstances is surgery still justified? Personal results and literature review]. / AC-Gelenksprengungen Typ Tossy III. Was sollen wir noch operieren? Eigene Ergebnisse und Literaturübersicht.

In Germany AC-joint-dislocations type Tossy III are treated in most of the cases operatively. Over two times of period we treated AC-joint-dislocations type Tossy III with biodegradable PDS-cords. 54 patients were operated between 1989 and 1997 and followed up after 39 months. 87.5% of patients are satisfied with results and have 10.2 points at Taftscore. In this period we couldn't differentiated the results by Rockwood classification. 12 patients with Rockwood V were operated between 1998 and 2002 and followed up after 14 months. Excellent and good results were seen in 92% of cases. At Taftscore we seen 10.7 points. 3 patients with Rockwood III were treated conservative with 10.3 points and 3 patients were operated with 10.7 points at Taftscore. AC-joint dislocations should be classified to Rockwood. No differences were seen between operation and conservative treatment in Rockwood III in literature. We recommend operation with PDS cords with good results in Rockwood V.

[Trauma in the last trimester of pregnancy]. / Trauma im letzten Trimenon der Gravidität.

Although accidents during pregnancy are fairly rare, besides endangering the mother, they nearly always mean a vital threat to the fetus: lethality rates are up to 8% for the mother and up to 34% for the fetus. Besides depression of the circulatory system in the mother, coupled with fetal hypoxy, injury to the placenta and uterus is also possible. Moreover, the unborn child may be injured by direct trauma. If the fetus sustains a direct injury, the head of the child is affected in the majority of instances. In addition, the risk of an intrauterine death is very high. If the injured baby survives after a section, permanent damage must be taken into account. Pregnant women who are injured in an accident should quickly be checked by sonography and cardiotocography. If no danger is expected for the child, the usual therapeutic rules that apply for traumatology should be followed. If the mother and child are endangered, a cesarean section must be undertaken along with simultaneous accident-related surgery on the mother. Case reports are presented on three cases in our clinic last year, and the current literature is discussed. All three mothers and newborns survived because of the cooperation between surgeons, gynecologists and pediatricians.

Biodegradable implants in sports medicine: the biological base.

Biodegradable implants are increasingly used in the field of operative sports medicine. Today, a tremendous variety of implants such as interference screws, staples, sutures, tacks, suture anchors, and devices for meniscal repair are available. These implants consist of different biodegradable polymers that have substantially different raw material characteristics such as in vivo degradation, host-tissue response, and osseous replacement. Because these devices have become the standard implant for several operative procedures, it is essential to understand their biological base. The purpose of this report is to provide a comprehensive insight into biodegradable implant biology for a better understanding of the advantages and risks associated with using these implants in the field of operative sports medicine. In particular, in vivo degradation, biocompatibility, and the osseous replacement of the implants are discussed. A standardized classification system to document and treat possible adverse tissue reactions is given, with special regard to extra-articular and intra-articular soft-tissue response and to osteolytic lesions.

Membrane versus bubble oxygenator in hyperthermic regional perfusion: a prospective randomized clinical study.

In a prospective randomized clinical study a routinely used bubble oxygenator (Bentley-5) was compared with a hollow fiber membrane oxygenator (D 701 Masterflo 34) during hyperthermic isolated extremity perfusion. This was done to find out whether there were differences between the two oxygenators in hemolysis, cellular damage, oxygenation and temperature achieved during extremity perfusion. In 30 perfusions blood samples were obtained at defined times: plasma hemoglobin (Hb), serum lactate dehydrogenase (s-LDH), number of erythrocytes, mean corpuscular volume (MCV), hemoglobin and bilirubin were determined for hemolysis, leukocyte count (neutrophils, lymphocytes, monocytes) and platelets as a check for cellular damage, and PO2, PCO2, O2 saturation and pH to define blood oxygenation and CO2 elimination. Maximal increase in temperature after 30 min and perfusion time until maximum tissue temperature were also recorded. The membrane oxygenator yielded better results from the aspect of hemolysis: s-LDH and plasma Hb were significantly different (p < 0.001). Cellular damage was less with the membrane oxygenator: platelet differences were significant (p < 0.01). Oxygenation and hyperthermia were obtained more quickly and were better controllable in membrane oxygenator. Further advantages for the patient were the smaller volume of blood needed for priming in a membrane oxygenator (750 vs. 1,200 ml) and improved safety resulting from a 'closed' perfusion system. On the basis of the clinical prospective randomized trial conducted, we conclude that membrane oxygenators must be adopted as the new standard in isolated hyperthermic extremity perfusion.