[Legal position of non-medical personnel in hospitals]. / Rechtliche Stellung nichtärztlichen Personals im Krankenhaus.

There are currently many assistant professions in the German healthcare system which have either a more nursing or a more medical character. All these assistant professions have in common that as yet they do not require uniform training criteria but members of these professions undertake some aspects of medical activities. At the center lies the difficulty of more political than legal discussion on whether members of these assistant professions and also nursing personnel are allowed to or should undertake medical activities. This article illuminates the legal status quo.

Effects of maleimide-polyethylene glycol-modified human hemoglobin (MP4) on tissue necrosis in SKH1-hr hairless mice.

OBJECTIVE: Tissue hypoxia after blood loss, replantation and flap reperfusion remains a challenging task in surgery. Normovolemic hemodilution improves hemorheologic properties without increasing oxygen carrying capacity. Red blood cell transfusion is the current standard of treatment with its attendant risks. The aim of this study was to investigate the potential of the chemically modified hemoglobin, MP4, to reduce skin flap necrosis and its effect on selected blood markers and kidneys. MATERIALS AND METHODS: Tissue ischemia was induced in the ear of hairless mice (n=26). Hemodilution was performed by replacing one third of blood volume with the similar amount of MP4, dextran, or blood. The extent of non-perfused tissue was assessed by intravital fluorescent microscopy. RESULTS: Of all groups, MP4 showed the smallest area of no perfusion (in percentage of the ear +/- SEM: 16.3% +/- 2.4), the control group the largest (22.4% +/- 3.5). Leukocytes showed a significant increase in the MP4 and dextran group (from 8.7 to 13.6 respectively 15.4*109/l). On histology no changes of the kidneys could be observed. CONCLUSION: MP4 causes an increase of leukocytes, improves the oxygen supply of the tissue and shows no evidence of renal impairment.

[Diagnosis of chronic osteitis of the bones in the extremities. Relative value of F-18 FDG-PET]. / Diagnostik der chronischen Osteitis des Extremitätenskeletts : Stellenwert der F-18-FDG-PET.

BACKGROUND: Noninvasive diagnosis continues to present a challenge in chronic bone infections. Positive intraoperative microbiological and/or histological results are regarded as the gold standard for confirmation of the diagnosis. The aim of the present study was to evaluate the value of F-18 FDG-PET in the diagnosis of chronic osteitis in the patients of a department devoted specifically to septic orthopaedic surgery. In particular, the study was intended to answer the question of whether the results of FDG-PET correlate with those found in intraoperatively removed biopsy specimens (microbiology, histology) and what value this method of investigation has relative to computed tomography (CT) and magnetic resonance imaging (MRI). METHODS: An F-18 FDG-PET examination was performed preoperatively in each of 50 patients with a suspected diagnosis of "chronic osteitis of bone/s in a limb". All these patients had a history of an open fracture and/or a previous operation on the affected limb. The FDG-PET results were analysed blind. All patients enrolled in the study were subsequently operated on. After surgery, the results of histological and microbiological examination of the biopsy specimens taken intraoperatively were compared with the results of the FDG-PET and of CT (n=22) and MRI (n=18). Finally, the sensitivity, specificity and accuracy of each method were determined. RESULTS: Postoperatively the biopsy specimens from 37 patients yielded positive results in the microbiological and/or histological tests. According to this gold standard, then, osteitis was not present in 13 patients. In the preoperative FDG-PET report 34 of the patients whose microbiological and/or histological results were positive were correctly diagnosed as infection positive. In addition, 4 false-positive results were observed. False-negative results were recorded in 3 patients and true-negative results, in 9. The sensitivity and specificity were 92% and 69%, respectively, for the entire group of patients. The accuracy was 86%. The sensitivity, specificity and accuracy were 47%, 60% and 50%, respectively, for CT and 82%, 43% and 67%, respectively, for MRI. CONCLUSION: F-18 FDG-PET is a promising diagnostic imaging method with high sensitivity and accuracy in the investigation of chronic osteitis. If the result of FDG-PET is negative chronic osteitis can be virtually excluded. The results presented suggest that it is superior to CT and MRI in sensitivity and accuracy. A definitive diagnosis of chronic osteitis will continue to require an invasive method in the future, in the form of removal of biopsy specimens for microbiological and histological tests.

[Operative standardization in randomized controlled surgical trials. Meeting of the INSECT trial]. / Operative Standardisierung bei randomisiert kontrollierten Studien in der Chirurgie. Studientreffen der INSECT-Studie.

BACKGROUND: INSECT is an internationally registered, three-armed, multicentre, intraoperatively randomised model trial of the Study Centre of the German Surgical Society. The interventions being compared are running suture technique with slowly absorbable monofilament suture material (PDS vs MonoPlus) and interrupted technique with a braided, rapidly absorbable suture material (Vicryl). The primary endpoint is the rate of incisional hernias 1 year postoperatively. MATERIAL AND METHODS: A total of 25 surgeons from 24 different institutions at all levels of care evaluated the theoretical and practical sessions of the surgical investigator meeting using 25 criteria, including course organisation, content, and speaker evaluation, and a categorical grading system from 1 (very good) to 6 (insufficient). RESULTS: Distribution of the 625 grades was: very good (1) n=367, good (2) n=207, satisfactory (3) n=39, adequate (4) n=2, and "No statement" n=10. The average score for the investigator meeting was 1.5. CONCLUSION: The participants felt they were successfully prepared theoretically and practically for trial interventions and conduct by attending the meeting. Clear explanation of the measures for treatment equivalence before and during trials is mandatory in randomised controlled surgical trials.

3-phase bone imaging and SPECT in the follow up of patients with allogenic vascularized knee joint transplants.

UNLABELLED: Vascularized allotransplantation of knee joints under immunosuppression is a novel approach in orthopedic surgery. During the postoperative course immunosuppressive management depends on perfusion and viability of the graft. AIM: Evaluation of different diagnostic tools in regard to their usefulness and reliability to provide information about microvascularity and viability of vascularized knee joint allografts. METHODS: Four patients with allogenic knee joint transplants were studied up to 26 months after transplantation with 3-phase bone scans and SPECT. The results were compared with duplex sonography, angiography, and histology. RESULTS: Two cases without complications were characterized by adequate perfusion in duplex sonography, angiography and early bone scans. Late bone scans demonstrated increased bone metabolism of the transplant. Corresponding biopsy revealed viable bone cells. In one case with partial thrombosis and one case with complete thrombosis of the transplant vessels rapidly decreasing or missing perfusion was detected by duplex sonography, angiography, and bloodpool scintigraphy. Late bone scans showed reduced or absent bone metabolism. Biopsy demonstrated necrotic bone tissue. Due to the advantage of a tomographic technique SPECT allowed a more reliable assessment of graft viability as compared to planar imaging. CONCLUSION: Our findings confirm bone scintigraphy as a valuable diagnostic tool in patients with allogenic vascularized knee joint transplants. In contrast to other diagnostic approaches, scintigraphy provides reliable information on both viability and perfusion of the transplant within a single non-invasive clinical investigation.

Vascularised knee joint transplantation in man: the first two years experience.

OBJECTIVE: To describe our early experience with a new technique for restoring destroyed knee joints to give reasonable functional results. DESIGN: Observational clinical trial. SETTING: Level-1-Trauma centre, Germany. SUBJECTS: 5 patients with large bone defects of the knee and loss of the extensor apparatus caused either by serious injury alone, or infection after serious injury. INTERVENTIONS: Transplantation of fresh and perfused knee joints with a vascular pedicle from multiorgan donors under immunosuppression. MAIN OUTCOME AND MEASURES: Ability to walk, need to remove one transplanted joint. RESULTS: Four patients are able to walk, the range of movement being from 50 degrees-120 degrees. The first patient additionally had to be provided with a total knee joint arthroplasty. In the third patient the graft became infected and had to be removed. She finally had an arthrodesis and bone lengthening by the Ilizarov technique. CONCLUSIONS: Transplantation of the knee joint may be an alternative to bone lengthening or amputation for patients with total loss of the extensor apparatus.

Clinical experience in allogeneic vascularized bone and joint allografting.

The allotransplantation of vascularized femoral diaphyses and total knee joints is a novel approach in orthopedic surgery. Allogeneic femoral diaphyses were transplanted into three patients suffering from chondrosarcoma or posttraumatic defects. Total knee joints allografts were transplanted in five patients with large bone defects of the knee and loss of the extensor apparatus caused either by major trauma alone or infection after a major trauma. Bone segments and total joints were harvested from multi-organ donors, perfused with UW-solution and transplanted within cold ischemia times of 18-25 h. Patients were immunosuppressed postoperatively primarily with cyclosporine (Cyclosporin A) and azathioprine. Two allografts (1 femur, 1 knee) were lost due to infections. Seven of the eight patients are able to walk with full weight-bearing posttransplant. Two of the patients with transplanted joint allografts subsequently received total knee arthroplasty implantations. Vascularized bone and joint allotransplantation may serve as a last line of defense treatment before considering lower limb amputation.

Use of three-phase bone scans and SPET in the follow-up of patients with allogenic vascularized femur transplants.

The vascularized allotransplantation of femoral diaphyses under immunosuppression is a novel approach in orthopaedic surgery. To evaluate which method provides the best information about microvascularity and viability of the transplant, we compared different diagnostic approaches used in transplant surgery. Three patients were investigated four times over a period of 1 month (on days 2, 7, 15 and 30 post-transplantation) and 6 and 12 months later with planar 99Tcm-MDP three-phase bone scintigraphy and SPET. The results were compared with duplex sonography, angiography and intraoperative biopsies. Rejection and thrombosis of the transplant were associated with decreased or missing perfusion detected by duplex sonography, angiography and blood pool scintigraphy. In these cases, late bone scans showed reduced or absent bone metabolism while biopsy revealed necrotic bone tissue. In cases without complications, blood pool scans revealed hyperaemia of the graft indicating excellent perfusion and patency of vascular anastomoses and transplant vessels. Late bone scans demonstrated increased bone metabolism. The corresponding biopsies showed viable bone cells. We conclude that bone scintigraphy is a valuable diagnostic tool in vascularized femur allotransplantation, since it provides reliable information on both viability and perfusion of the transplant within a single non-invasive investigation.

[Allogeneic vascularized transplantation in cases of bone and joint defects]. / Uberbrückung langstreckiger Knochen- und Gelenkdefekte durch allogene vaskularisierte Transplantate.

This paper presents preliminary results of allogeneic vascularized transplantations of three femoral diaphyses and four total human knee joints. Grafts were harvested from multi-organ-donors and immediately transplanted. Osteosyntheses were performed employing intramedullary nails. Vascular pedicles of the grafts were anastomosed in end-to-side technique. Immunosuppression mainly based on Cyclosporine and Azathioprine. Grafts' perfusion was demonstrated by DSA and Duplex-sonograms, bone metabolism by SPECT-scintigraphy. Five months following transplantation osteotomies demonstrated consolidation in conventional X-rays. Biopsies of the grafted bone revealed intact osteocytes and arthroscopy demonstrated intact synovial, chondral and ligamentous structures. From the technical aspect vascularized transplantation of the femoral diaphyses and total knee joints is feasible. The main problems are of immunologic nature. Transplantations were performed respecting the ABO-compatibility but with a large HLA-mismatch. Acute and chronic rejection crises may damage the grafts. At least in synovial joints live-long immunosuppression of the recipients seems to be unavoidable.

Allogeneic vascularized transplantation of human femoral diaphyses and total knee joints--first clinical experiences.

This article has presented the preliminary results of three patients who received vascularized allogeneic femoral diaphyses and three patients having undergone vascularized transplantation of fresh and perfused total human knee joints. The large osseous defects in the femora followed osteomyelitis and chondrosarcoma. The three knee joints were lost due to various trauma mechanisms. All grafts were harvested within 25 hours from multiorgan donors perfused with 4 L of UW solution. All osteosyntheses were performed employing intramedullary nails. Vascular pedicles of the grafts were anastomosed end-to-side to the superficial femoral artery and vein in the adductorial canal of the recipient thigh. Immunosuppression was based mainly on two drugs: CyA and AZA. Perfusion of the grafts was demonstrated by DSA, and bone metabolism in the graft by SPECT scintigraphy. Six months after the operation all osteotomies demonstrated callus formation and osseous consolidation in conventional radiographs. Biopsies of the grafted bone revealed intact osteocytes, and arthroscopy of the transplanted knee joints demonstrated intact synovial, chondral, and ligamentous structures. From the surgical aspect, the vascularized transplantation of the femoral diaphyses and total knee joints is technically feasible. The main problems are immunologic. All transplantations were performed with respect to ABO compatibility, but with a large HLA mismatch. Therefore, acute and chronic rejection crises were observed. In total synovial joints, lifelong immunosuppression of graft recipients seems to be currently unavoidable.

Allogeneic vascularized grafting of human knee joints under postoperative immunosuppression of the recipient.

Vascularized knee joint transplantations have been performed in various animal systems. Up to now no allogeneic vascularized transplantation of a fresh and perfused human knee joint has been realized. This paper reports on the first four grafted human knee joints, performed between April 1996 and July 1997 at the Trauma Center Murnau. The indication for transplantation of a human knee joint is total loss of the joint, including the extensor apparatus, following severe trauma. Management of this defect is first to effect closure of the soft tissue defect combined with external transfixation and bone cement spacers. For the second phase the external stabilization is switched to internal stabilization using femoral tibial nails and a temporary knee joint prosthesis manufactured of polyethylene. The transplantations are performed with respect to ABO compatibility, ignoring the HLA system after a negative crossmatch. Osteosyntheses are employed by femoral and tibial nails. The vascular anastomoses are established in an end-to-side technique between the recipient's superficial femoral vessels and the graft vascular pedicles. Immunosuppression starts as quadruple induction therapy for 3 days. Subsequently it is reduced to a two-drug maintenance protocol with cyclosporin A and azathioprine. We utilize radiography, digital subtraction angiography, duplex sonography, scintigraphy, and arthroscopy for graft monitoring. Six months after transplantation the osteotomies were bridged with callus, and the patients were completely mobilized. The motion in the transplanted knee joint ranges from complete extension to 110 degree flexion.

Importance of arterial blood supply to the femur and tibia for transplantation of vascularized femoral diaphyses and knee joints.

The role of the periosteal and intraosseous blood supply to the femur and the proximal tibia was investigated to improve the operating technique for transplantation of allogenic vascularized femoral diaphyses and knee joints in humans. Altogether 48 limbs were injected with gelatin, red latex milk, or Revertex and macroscopically prepared; 41 limbs were studied for the variation and division of the truncus profundo-circumflexus. In 200 femurs and 200 tibias the location of the nutrient foramen was determined. The arteries supplying the periosteum of the distal femur and the proximal tibia have defined nutritive areas. The following technique should be followed: If the femoral artery alone is prepared as the vascular pedicle, the optimal section for resection of the femur in knee joint transplantations is 6 to 12 cm above the level of the femur condyles and 5 to 7 cm below the tibial plateau. For the transplantation of femoral diaphyses, the deep femoral artery can be used if the lateral femoral circumflex artery is protected. The Proximal line of resection is defined between the greater and lesser trochanter. For shorter grafts one must consider the number and location of nutrient foramens. For longer grafts the distal branches of the femoral artery must be respected as the intraosseous blood supply reaches distally down to the level of about 8 cm above the femoral condyles. In all these operations of the variation of the truncus profundo-circumflexus and the trifurcation of the popliteal artery must be considered.

Vascularized knee joint transplantation in man: a report on the first cases.

Four transplantations of an allogeneic vascularized human knee joint were performed at the Trauma Center Murnau between April 1996 and July 1997. The indication for the procedure was the total loss of the knee joint including the extensor apparatus due to severe trauma. These were the first transplants of this type. Management of patients started with closure of soft-tissue defects. After successful completion, stabilization was achieved with femoral and tibial nails plus a temporary arthroplasty. AB0 compatibility and a negative cross-match were the main criteria for selecting patients for transplantation. Interlocking compression nails were used for osteosynthesis. Vascular anastomoses between graft and recipient vessels were established by the end-to-side technique. Immunosuppression was started as a quadruple induction therapy for 3 days, then reduced to a two-drug maintenance therapy with cyclosporine and azathioprine. Six months posttrans-plantation the osteotomies were bridged by callus and the patients became completely mobile. Radiographic and histological examinations revealed vital graft tissue.

Allogenic grafting of vascularized bone segments under immunosuppression. Clinical results in the transplantation of femoral diaphyses.

Trauma surgery lack, substitute, for the reconstruction of large defects of the long bones. Encouraged by the promising results of bone allotransplantation in animal models, we successfully performed vascularized bone transplantation in humans. Vascularized femoral diaphyses were allogenically transplanted into three patients suffering from chondrosarcoma or post-traumatic osteomyelitis with postoperative immunosuppression. The bone segments were harvested from multi-organ donors and perfused with UW solution. After back-table preparation, the grafts were transplanted into the defect zone. Interlocking devices were used in these operations. Vascular anastomoses were performed in end-to-side technique. The early clinical course of the patients was not free of anatomical, technical, or immunological complications. However, all patients are currently free of malignancy and infection. They are also free of pain and full weight bearing. We conclude that allogenic grafting of vascularized bone segments has the potential to become an alternative for the replacement of large bone defects.

[Bridging long bone and joint defects with allogeneic vascularized transplants]. / Uberbrückung langstreckiger Knochen- und Gelenkdefekte durch allogene vaskularisierte Transplantate.

Three patients with large osseous defects following trauma and infection received vascularized allogeneic femoral diaphyses and five patients vascularized allogeneic total knee joints. From the surgical aspect these transplantations are technically feasible. The remaining problems are of immunological nature; at least in patients with allogeneic synovial joints, lifelong immunosuppression seems to be currently unavoidable.

The arterial blood supply of the human patella. Its clinical importance for the operating technique in vascularized knee joint transplantations.

The architecture of the arteries supplying the patellar rete was examined in 14 anatomic specimens in order to develop an optimized operating technique for knee joint transplantation. The specimens were fixed in Jores Solution and exarticulated from the hip joint. The lower limbs were injected with Berliner-Blau-Gelatin, and the arteries were dissected macroscopically. Five to six main arteries entered the patellar rete at 1, 3, 5, 7 and 11 o'clock forming an arterial circle. These arteries were the same main arteries which supply the distal end of the femur and the proximal part of the tibia. From an anatomic perspective, they provide the complete arterial blood supply to a whole knee joint being transplanted including the patella. Based on these anatomic results, we transplanted two allogenic vascularized human knee joints preserving the patella, the capsule, and the patellar ligament. Up to six months after surgery we demonstrated the perfusion and viability of all three transplanted bones, particularly the patella, by 99mTc DPD scintigraphy. We compared these findings with knee joint arthroscopy and with histologic results from biopsies taken from the patella. The postoperative examinations clearly indicated the viability of the transplanted patella employing this new operating technique. The results of the entire study demonstrate that it is technically feasible to transplant a whole knee joint which remains clinically viable.

Allogeneic vascularized grafting of a human knee joint with postoperative immunosuppression.

In this paper we report the first successful allogeneic vascularized transplantation of a fresh and perfused human knee joint. A 17-year-old male had lost his knee in a motorvehicle accident. The graft was harvested from a multiorgan donor, perfused with 41 UW solution and transplanted within 21 h. Osteosyntheses were performed employing intramedullary nails. Immunosuppression was based mainly on two drugs: cyclosporin A and azathioprine. Five months after the operation the patient is fully mobilized, and the graft perfusion still intact. Osteotomies of the femur and tibia demonstrate callus formation and osseous consolidation.