[Consequence of European Directive 2004/23/EC for bone banks in Germany]. / Auswirkungen der EU-Geweberichtlinie 2004/23/EG auf deutsche Knochenbanken.

Allogenic bone grafting is an established method in revision surgery of artificial joint replacement and spinal surgery in case of bone defects. In Germany, femoral heads from living donors undergoing total hip replacement are frequently used. These grafts are processed according to the "Guidelines for the management of bone banking" issued by the Federal Medical Board. Bone grafts are drugs according to German law. Local bone banks are excluded from the regulations of the federal law on drugs [Arzneimittelgesetz (AMG) section sign 4a (4)] if certain requirements are fulfilled. The Directive 2004/23/EC of the European Parliament and of The Council on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells has to be implemented into national law within 2 years. The exception of section sign 4a (4) will no longer be possible. Thus a legal construction has to be found which allows running local bone banks in compliance with the new legal settings. Three conditions will be possible: (1) a single physician procures a graft for another patient of his, (2) grafts are procured in one hospital and are used exclusively in this hospital: a license from the local authorities and a strict quality assessment according to GMP-rules is required, (3) if the grafts are distributed to other hospitals, a license from the local authorities and registration as a drug by the federal authorities are necessary.

[Inactivation of HIV-1 in human femur heads using a heat disinfection system (Lobator SD-1)]. / Untersuchungen zur Inaktivierung von HIV-1 in humanen Femurköpfen durch Verwendung eines thermischen Desinfektionssystems (Lobator SD-1).

The use of allogenic bone transplants in surgery has been greatly diminished owing to the risk of transmitting infectious diseases. This risk can be reduced by the use of a thermal disinfection system (Lobator SD-1). This is achieved by increasing the temperature to 80 degrees C, inactivating a number of bacterial and viral agents. In this study the decay of HIV at high temperature in the Lobator SD-1 was researched. In the center of human femoral heads 100 microliters of a highly concentrated suspension of free and cell-bound HIV (10(10)) was exposed to the thermal process at intervals of 5, 10, 20, 30, 40, 50 and 62 min. For the recultivation HUT-78 cells were used through titration of the virus suspension in ten-fold dilutions over ten dilution steps and incubation up to a maximum of 21 days. Evidence of the virus was checked through observing giant cell formations and quantitative determination of p24 antigen using an Elisa test. Linear virus inactivation was found based upon the time the virus was exposed to heat. After a treatment of 40 min in the disinfection system, total virus inactivation was achieved. The normal disinfection process time using Lobator SD-1 is 92 min. A temperature of 80 degrees C is reached after approximately 45 min. The results prove that this system totally inactivates HIV in human femoral heads.

[Considerations in differential therapy of insufficiency of the anterior cruciate ligament. Principles and clinical consequences]. / Uberlegungen zur differenzierten Therapie bei Insuffizienz des vorderen Kreuzbandes. Grundlagen und klinische Konsequenzen.

Ruptures of the anterior cruciate ligament are among the most frequent injuries of the joints. There is no longer any doubt regarding the necessity for surgical intervention. Several clinical and experimental studies suggest that the instability of the knee joint results in an accelerated degeneration of the menisci and cartilage. There are differences of opinion regarding the type of surgical procedures to stabilize the knee-joint. Although there are many different surgical procedures described in various publications, only one technique emerges as the preferred one. This paper will demonstrate different therapeutic concepts, based on the biomechanical background for the treatment of the anterior knee instability. It will consider the morphology of injuries, the demands of the patient and the full range of rehabilitative possibilities. Described herein are the indications and techniques of augmentation, protection and prosthetic replacement.

[The new "Marburg rehabilitation concept". "On the status of exercise equipment within the scope of rehabilitation of patients after surgery of the anterior cruciate ligament"]. / Das neue "Marburger Rehabilitationskonzept". "Uber den Stellenwert von Ubungsgeräten im Rahmen der Rehabilitation von Patienten nach Operationen am vorderen Kreuzband".

The surgical treatment of acute and chronic injuries of the anterior cruciate ligament (ACL) is still incontinous. Different techniques and materials are used to reconstruct and repair this important structure. This causes that the kind of postoperative treatment is even inhomogeneous. Concepts of "early mobilization" correspond to the results of basic research on pathobiomechanical effects of joint immobilization. There is a large variety on the information concerning method, success and length of rehabilitation. The final aim of our research was the development of a new rehabilitation strategy for patients in addition to out-patient physiotherapy. The reconstruction and repair of ACL is in our hospital done by an autograft of patellar tendon, "bone-tendon-bone", in augmentation with a "3-mm-Trevira cruciate ligament prosthesis". In our prospective, controlled and randomized clinical study "group A" (n = 20) practiced in addition to their out-patient physiotherapy twice a week under the direction of a medical doctor and the control of a physiotherapist with the equipment of a fitness-center. "Group B" (n = 20) passed only the out-patient physiotherapy. Both groups were examined regularly with special regard to the active motion of the knee joint, the power and the circumference of the leg. Also the "Marschall-Tegner" and the "Lysholm-Gilquist-Score" were determined. In our study we found that the "New-Marburg-rehabilitation-concept" is an useful supplement to the out-patient physiotherapy. All examined data showed a clear increase in "group A" in comparison to "group B".

[Experimental studies of thermal disinfection and sterilization of allogeneic bone transplants and their effects on biological viability]. / Experimentelle Untersuchungen zur thermischen Desinfektion und Sterilisation allogener Knochentransplantate und deren Auswirkungen auf die biologische Wertigkeit.

Thermal energy (80 degrees) for the disinfection of cancellous allogenic bone grafts was employed, and it proved to be an advantageous, safe and easily accessible method. The effects of this treatment on biological values were examined in terms of biomechanical and biodynamic (graft incorporation) loss of the treated grafts versus the autoclaved and untreated samples. Given the thermolability of the pathogens in question, the thermal approach presented here has the advantage of being readily controllable. The lack of toxic or mutagenic risks through this method and its accessibility represent further advantages. In thermal treatment of bone allografts, it is essential that one knows the thermoconductivity of the bone sample and that one can demonstrate pathogen inactivation through the entire graft volume. All of the parameters in the 80 degrees C group that were measured in this study indicate clear biological superiority over the autoclaved group. A newly developed thermoincubator is introduced for gentler disinfection of allogenic bone grafts and it inactivates common vegetative pathogens as well as HIV. It is still necessary to conduct serological screening for hepatitis antigens in the donor pool, however. Based on these results, we conclude that the clinical use of autoclaved allogenic bone grafts needs to be reviewed and possibly limited.

[Emergency diagnosis of sternum fracture with ultrasound]. / Notfalldiagnostik der Sternumfraktur mit Ultraschall.

Fractures of the sternum often are not discernable on X-rays. The standard lateral X-ray of the sternum may allow the diagnosis. The aim of this study was to find out whether sternal fractures can be visualized by ultrasound. The flat, plane and broad bone provides an ideal rest for a linear scanner; the one used in our study had 5 MHz. We show that sternal fractures can easily be diagnosed by means of ultrasound, and because of an interruption of the cortical reflex, possibly better than on radiographs. We also wanted to show whether sonography, which is in widespread use for the diagnosis of blunt abdominal trauma, can also be used in an emergency situation of blunt thoracic injury (e.g. seat belt injury). In 16 cases of fractures of the sternum already diagnosed by X-ray, an examiner unacquainted with the X-ray results was able to locate and diagnose all fractures by ultrasound within 1 min.

[Distraction of the first metacarpal bone for thumb reconstruction]. / Die Distraktion des ersten Mittelhandknochens zur Daumenersatzbildung.

After amputation of the thumb good functional results can be achieved by lengthening the first metacarpal bone, if a suitable technique is used. Since 1987 we have treated six patients in this way. In all of our patients the thumb was mechanically stable and sensitive after lengthening, thus improving the patients' ability to use their hands for grasping. Other advantages include the relative simplicity of the method, the fact that no experience of microsurgery is necessary and that the surgery does not result in soft tissue damage. In most cases treatment is on an outpatient basis. Between the various operations the patient can be reintegrated into his professional and social life. The period of absence from work (about 12 weeks) is relatively short when the severity of the injury is taken into consideration. Distraction of the first metacarpal bone cannot be considered an alternative to replantation but represents a complementary procedure in accordance with the modern management of severe hand injuries.

[Studies on HIV inactivation in allogeneic bone transplants using chemical disinfection and radioactive irradiation]. / Untersuchungen zur HIV-Inaktivierung in allogenen Knochentransplantaten durch chemische Desinfektion und radioaktive Bestrahlung.

In our study we examined bone disinfection by ethanol and by irradiation. A 70% aqueous ethanol solution diffused through a 3 mm and a 6 mm slice of human cancellous bone against 2 ml of a HIV-sample (RTA: 300,000 cpm/ml) for 24 hours. In both cases HIV could not be inactivated. Infected T-lymphocyte cultures showed specific morphological cell changes. The Abbott HIV-antigen-EIA proved the treated HIV-samples to be infectious after cultivation in macrophage-cultures. Additional gas chromatography measurements of ethanol diffusion through 3 mm and 6 mm of human cancellous bone supported these observations: a 70% aqueous ethanol solution achieved a concentration of 25.6% (18.0%) in median after 24 hours and a thickness of 3 mm (6 mm). The effect of different doses of irradiation on HIV-samples (RTA:300,000 cpm/ml) was examined. The samples were irradiated with 2, 7, 10, 15 and 25 kGy to determine the appropriate dose for inactivation. Irradiation with 15 kGy caused HIV inactivation since no virus production could be detected in the macrophage culture (Abbott HIV-antigen-EIA). The samples irradiated with 2, 7 and 10 kGy were still infectious.

[Biomechanical properties of heat and irradiation treated spongiosa]. / Biomechanische Eigenschaften thermisch und radioaktiv behandelter Spongiosa.

Cylindrical specimens of trabecular pig bone were tested to uniaxial compressive strain levels of 30% to study the influence of various sterilization techniques and methods of HIV-inactivation on the mechanical properties characterized by compressive modulus, yield point, energy absorption and maximum stress. Heat inactivation at 60 degrees C (Lactated Ringer, 1 h) showed no effect; 80 degrees C (Lactated Ringer, 1 h) resulted in a diminution of the yield point and the maximum stress (p less than 0.005), while energy absorption and compressive modulus were not affected. No reduction in the stability was seen when ethanol was used instead of Lactated Ringer. At a temperature of 100 degrees C, all measured parameters were reduced to approximately 60% compared with the control group. A decrease to 13% to 25% was seen after autoclavation (120 degrees C, 2 bar, 20 min and 134 degrees C, 3 bar, 12 min). Irradiation (60Co) with 3 respectively 10kGy did not impair the stability, whereas a dose of 25 kGy led to a reduction to 61% to 69%. No additional effect was seen when irradiation was followed by storage at -80 degrees C for one week. These effects on bone stability should be considered when choosing a method of bone preparation to obtain HIV-inactivated bone grafts. Autoclavation should be used with caution when stability of the bone graft is essential. In this case, irradiation seems to be a safe method of sterilizing bone grafts ensuring both a high degree of safety and stability.

[The bone bank--a standardized procedure? Results of a federal survey of German surgical clinics]. / Die Knochenbank--ein standarisiertes Verfahren? Ergebnisse einer bundesweiten Umfrage an deutschen chirurgischen Kliniken.

An inquiry at German surgical departments about their bone bank techniques showed that 45% of clinical hospitals use allogeneic bone implants among other implants. In 1989, the year of the official survey, allogeneic bone was transplanted about 6000 times in these clinical hospitals. Despite of this high transplantation frequency important differences turn out regarding selection and testing of recipients, transplantation storage and treatment. A lot of clinical hospitals do not perform important donor examinations inspite of proven transmission risks of bacterial and viral diseases by deep frozen bone. A trend analysis shows that despite of the risk of an HIV-transmission and the resulting difficulties in the logistic of the bone bank, the transplantation frequency allogeneic bone stays constant. The official surveys prove the large range of bone bank techniques and should give rise to make efforts to take note of the recommendations for bone banking techniques.

[Immunization against blood group antigens by allogeneic bone transplantation]. / Immunisierung gegen Blutgruppenantigene durch allogene Knochentransplantation.

33 bone allotransplants (cryopreserved) of AB0- and Rh-incompatible (donor-recipient) patients were performed to evaluate the question which AB0 Rh-incompatibility leads to immunization of the bone transplant recipient. Several different antibodies were tested pre- and postoperatively in the recipient. Regarding the Rh-system no immunization was demonstrable; however, a significant increase of antibody leads was found regarding the AB0-system. Thus, in bone bank techniques AB0 compatibility is important for allogeneic bone transplantation in young women. Otherwise, there is a risk for the development of MHN in case of pregnancy. Blood group-typing is not necessary in other patient groups. Although no Rh-antibodies were demonstrable, a similar mechanism can be postulated for the Rh-system. We, thus, conclude that in allogeneic bone tx in young women the Rh-system has to be taken into consideration.

Plasma histamine levels in polytraumatized patients.

In a prospective clinical trial, plasma histamine levels were measured in 28 polytrauma patients on day 1, 5 and 14 after trauma. Only those subjects who died were drop-outs. All patients had severe polytrauma with at least 3 body regions involved. The median plasma histamine levels at all three time points were significantly higher than in patients with single trauma of the extremities or before selective orthopaedic surgery but still in the normal range (less than 1 ng/ml). However, all patients with plasma levels above 1 ng/ml on days 1 and 5 died, as did all patients with levels above 0.5 ng/ml on day 1. Thus the elevation of plasma histamine levels, for whatever reason, appears to be a prognostic factor for bad outcome in polytrauma patients.

Spontaneous fractures of the neck of the femur occurring in pregnancy in the absence of pregnancy osteoporosis.

Case report on a patient suffering from spontaneous fractures of the neck of the femur which occured during her first pregnancy at the age of 23 in the left leg and during another pregnancy seven years later in the right leg. Both fractures occured during the eighth month of pregnancy. Special attention is drawn to the fact that local or general osteoporosis which, according to literature, should be obligatory for the occurence of spontaneous necrosis of the femoral head and/or fractures of the neck of the femur, could be demonstrated neither during the first nor the second pregnancy.