A double-blind, multicentre, randomised clinical trial comparing the efficacy and tolerability of aceclofenac with diclofenac resinate in patients with acute low back pain.

The efficacy and tolerability of aceclofenac was compared with diclofenac resinate in a double-blind, multicentre randomised study in patients with acute low back pain suffering from degenerative spinal disorders. The study included 227 patients randomised to receive either aceclofenac 2 x 100 mg daily or diclofenac resinate 2 x 75 mg daily for up to 10 days. The primary objective was to demonstrate the clinical non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate, as assessed by changes from baseline in the visual analogue scale (0-100 mm) pain score, at rest and at visit 3 (final visit on day's 8-10). Secondary objectives included the time to early cure (resolution of pain) and global assessment of tolerability. Mean change in pain score at rest, and as visit 3, compared with baseline, was 61.6 mm (SD 24.5) for the aceclofenac group ( n = 100) and 57.3 mm (SD 22.8) for the diclofenac resinate group ( n = 105) in the per-protocol population. Similar changes were observed in the intention-to-treat population. Between-group differences of 4.5 mm and 5.5 mm for the per-protocol and intention-to-treat populations, respectively, demonstrated clinical non-inferiority of aceclofenac compared with diclofenac resinate. Furthermore, there was evidence for superiority of aceclofenac over diclofenac resinate in terms of statistical significance, as the one-sided 97.5% confidence interval was above -10 mm and 0 mm. In the intention-to treat population, a total of six aceclofenac-treated patients discontinued their medication owing to early cure, compared with only one patient receiving diclofenac resinate. Seventeen aceclofenac- (14.9%), and 18 diclofenac resinate-treated patients (15.9%) reported at least one adverse event. However, the total number of adverse events reported was lower in patients receiving aceclofenac (22 versus 31 in the diclofenac resinate group). In conclusion, non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate was demonstrated in patients with localised, uncomplicated acute lumbosacral pain. For the reduction in pain levels from baseline there was also evidence for superiority of aceclofenac compared with diclofenac resinate in terms of statistical significance, although this difference was not considered clinically relevant. The results also showed a trend towards a better safety and tolerability profile of aceclofenac over diclofenac resinate from a clinical point of view.

[Transplantation of allogeneic menisci]. / Transplantation allogener Menisken.

The increase in severe ligament injuries of the knee has led to consideration of the need for meniscal transplantation in reconstructive operations for chronic rotational instability. Transplantation of the medial meniscus was carried out in 30 sheep, which were divided up into 2 groups, each containing 15 sheep. In the first group lyophilized, y-sterilized allogeneic menisci were transplanted and these underwent complete remodelling in 48 weeks. In the other group, deep-frozen allogeneic menisci were used and these remained fully functional without remodelling. Twenty-three transplantations of the medial meniscus combined with replacement of the anterior cruciate ligament were performed from May 1984 to December 1986. Clinical follow-ups were coupled with arthroscopic follow-ups on an average of 10 months post-operatively in 19 sheep. In 17 cases a lyophilized meniscus was transplanted and in 6 cases a deep-frozen allogenous meniscus was used. There were no operation-specific complications in either group. Both the lyophilized meniscus transplants and the deep-frozen ones underwent a reduction in size during the observation period. Good-to-excellent results were generally obtained with the deep-frozen transplants; however, there is the risk of transmitting disease. The results seen in the lyophilized transplants were less satisfactory due to a reduction in size, sometimes down to the regeneration size. Taking the infrapatellar fatty pad for meniscal replacement (as suggested by Lexer), we saw only weak meniscus-like tissue after the first year postoperatively. The meniscus tendon by means of an autologous tendon for meniscus replacement may be an alternative procedure. Therefore, allogeneic meniscus transplantation for reconstruction of the knee joint cannot be recommended at present as a standard procedure.

[Current aspects of meniscus transplantation]. / Aktuelle Aspekte der Meniskustransplantation.

Meniscus transplantation is a common procedure for some orthopaedic surgeons all over the world. Deep frozen as well as freeze-dried meniscal allografts were transplanted. Reconstruction of the knee ligaments after meniscectomy as well as surgical therapy of osteochondral defects of the knee joint after meniscectomy are some of the indications for meniscus transplantation. Our own long-term results of freeze-dried meniscus, however, showed a degeneration of the transplants after two years up to a meniscus regenerate. Deep frozen meniscus transplants may be contaminated with virus (e.g. Hepatitis, AIDS). Taking the infrapatellar fatty pad for meniscal replacement (as suggested by Lexer) we saw only a weak meniscus like tissue after the first year postoperatively. The tendon meniscus by means of autologous tendon for meniscus replacement may be an alternative procedure. Therefore, meniscus transplantation cannot be recommended at present as a standard procedure for reconstruction of the knee joint.

[Visualized three-dimensional reconstruction and image analysis in orthopedics and trauma surgery]. / Visualisierte dreidimensionale Rekonstruktion und Bildanalyse in Orthopädie und Unfallchirurgie.

Computer tomography is a commonly used technique for detecting pathological alterations in soft tissue and the skeleton. The remote access to image informations as well as the allocation of display and processing tools via networks enables improved diagnostic and therapeutic practice in orthopaedic and traumatologic surgery. The realization of a user friendly image analysis system displays and processes the acquired images in a modality oriented manner. Our method is based on a unique file format and specific evaluation procedures to produce the input data for three-dimensional display and algorithms for the individual design of implants. Our image analysis system can process the data of conventional computer tomographies with three or more mm distance. In contrast to the available systems there is a low significance of radiation effects.

[Meniscus replacement using Hoffa's infrapatellar fat bodies--initial clinical results]. / Meniskusersatz durch Hoffaschen Fettkörper--Erste klinische Ergebnisse.

Between December 1986 and July 1988 a replacement of the absent medial meniscus was taken by means of the infrapatellar adipose body in seven patients. A replacement of the anterior cruciate ligament by means of the middle one third of the patellofemoral ligament was taken too. This operation was done for reconstruction of the synergism between the anterior cruciate ligament and the posterior horn of the medial meniscus. All patients are controlled in our special knee outpatient service. There were no complication postoperatively and on all seven patients a control arthroscopy was performed twelve months postoperatively. The subjective results are very satisfying because of the restoration of knee stability. The arthroscopic controls of the meniscal replacements, however, showed a reduction in size of the transplants after one year, the tissue was weak and not identical to that of a normal meniscus. Autologous strong tissue, e.g. quadriceps tendon, may have better presuppositions for meniscal replacement.

[Meniscus transplantation and anterior cruciate ligament replacement--results 2-4 years postoperative]. / Meniskustransplantation und vorderer Kreuzbandersatz--Ergebnisse nach 2-4 Jahren postoperativ.

23 transplantations of meniscus combined with replacement of the anterior cruciate ligament were performed from May 1984 to December 1986 at the Department of Orthopaedics of the University of Munich ('Klinikum Grosshadern'). Clinical follow-ups were coupled with arthroscopic follow-ups on the average 10 months postoperatively in 19 patients with transplantation of the medial meniscus of the knee joint. In 17 cases a lyophilised meniscus was transplanted and in 6 cases a deep-freeze allogenous meniscus. There were no operation-specific complications in either group. Both the lyophilised meniscus transplants and the deep-frozen ones underwent a reduction in size during the observation period. Whereas good to excellent results were generally obtained with the deep-frozen transplants, the results seen in the lyophilised transplants were less satisfactory due to reduction in size partly down to regenerate size. The treatment results were of course positively influenced due to the contributory effect of the regained stability; in the patients with meniscus transplants the preoperative Lysholm score was 72 +/- 14 points, on the average 36 weeks postoperatively 82 +/- 15 points. However, clinical and arthroscopic findings showed that no clinically, immunologically and morphologically satisfactory meniscus replacement has become available to date.

Methods and applications of three-dimensional imaging in orthopedics.

Computed tomography is a commonly used technique for detecting pathological alterations in soft tissues and the skeleton. Three-dimensional images of the skeleton are very useful for planning surgical treatment and monitoring therapy, but unfortunately mental reconstruction of complex three-dimensional anatomical structures from conventional tomography is very difficult. This article describes a process by which automated analysis of the regions of interest in the computed tomographic (CT) images yields the contours of the surfaces which can be presented pseudo-three-dimensionally using Phong's lighting model and Gouraud's shading methods. Three applications in the areas of orthopedics and neurosurgery demonstrate the efficacy of the method.

Homologous meniscus transplantation. Experimental and clinical results.

The increase in severe ligament injuries of the knee has led to consideration of the need for meniscal transplantation in reconstructive operations for chronic rotational instability. Transplantation of the medial meniscus was carried out in two groups of 15 sheep. In one group lyophilised, gamma-sterilised allogenic menisci were transplanted and these underwent a complete remodelling in 48 weeks. In the other group, deep frozen allogenic menisci were used and these remained fully functional without remodelling. We then carried out meniscal transplantation in 22 patients who were followed-up for a mean of 14 months. Arthroscopy was possible in two-thirds of the cases at an average of 8 months after operation. Both types of transplanted menisci, lyophilised and deep frozen, decreased in size, as small as a regenerated meniscus in some cases. In general the deep frozen menisci showed better results.

[Comparative studies on cadmium, chromium, nickel and lead accumulation in coxarthrosis and idiopathic femur head necrosis]. / Vergleichende Untersuchungen zur Cadmium-, Chrom-, Nickel- und Bleibelastung bei Coxarthrose und idiopathischer Hüftkopfnekrose.

Possible heavy-metal toxicity due to cadmium, chromium, nickel and lead in coxarthrosis and idiopathic necrosis of the head of the femur is reported on for the first time. Studies are made in the diseased head of the femur by means of ICP emission spectroscopy and atom absorption spectrophotometry. Whereas the blood and bone analyses in the own control group and in the coxarthrosis patients show normal values, a statistically significantly elevated element concentration in the head of the femur in the case of idiopathic necrosis of the head of the femur could be demonstrated with regard to the heavy-metal toxicity due to cadmium, nickel and lead. The analysis of the necrotic zone itself also shows considerable accumulations both for chromium and for nickel and lead. Since the analysed trace elements are strongly toxic in high concentrations, further clarification of a possible causal relationship between toxic trace element concentration and idiopathic necrosis of the head of the femur appears necessary.

Investigation of ischaemic necrosis of the femoral head with trace elements.

This preliminary report examines the possible disturbances in mineral and trace element metabolism in idiopathic ischaemic necrosis of the femoral head. Bony specimens from 45 femoral heads removed from patients with this condition were compared with 62 osteoarthritic and 10 normal femoral heads. Blood analysis was also carried out in the first two groups of patients, who were having joint replacement operations. The normal specimens were obtained at postmortem. Calcium, Magnesium, Iron, Copper, Manganese and Zinc were analysed in blood and bone by atom absorption spectrophotometry, and Cadmium, Chromium, Nickel and Lead by ICP emission spectroscopy. In ischaemic necrosis Magnesium and Copper are especially decreased, but the toxic trace elements Cadmium, Nickel, Lead and Chromium are found in a significantly higher concentration in the femoral head. It is submitted that these findings indicate the need for further investigation.

The results of reconstruction of the lateral ligaments of the ankle.

Eighty-one reconstructions of the lateral ligaments of the ankle were carried out at our clinics between 1967 and 1983. Three methods were used and 53 patients were followed up. The only two poor results followed infection after dural reconstruction. Peroneus brevis reconstruction, dural reconstruction and ligament advancement all had good results in over 80% of the patients. There was restriction of supination and an increase of osteoarthritis after the peroneus brevis reconstruction operations. Statistical analysis did not show that any one of these procedures was better than any other.

[Transplantation of the meniscus. Experimental study]. / La transplantation de ménisque. Etude expérimentale.

An experimental study has been made of the possibility of meniscus grafting. This was carried out in 30 merino sheep, 15 of which received lyophilised homologous menisci and 15 others deep-frozen homologous menisci. Three sheep had to be excluded because of wound breakdown and sepsis. The other animals were examined and the transplants assessed clinically, microscopically, micro-angiographically and by scanning electron microscopy over a period of 48 weeks; finally they were submitted to biomechanical tests. Both techniques are suitable for transplantation but, over the period of observation, the lyophilised grafts remodelled completely. At the end, the mechanical resistance of the meniscus was identical in the two groups.

[Results of the follow-up of varus osteotomy in Perthes disease with reference to the hip value]. / Behandlungsergebnisse der Varisierungsosteotomie bei Morbus Perthes unter Berücksichtigung des Hüftwertes.

A total of 89 patients with 105 hip joints affected by Perthes' disease at Catterall's stages II to IV, which had been treated by varus osteotomy, were re-examined clinically and radiologically between two and ten years after surgery. The clinical and subjective results of treatment were generally good. The best clinical and radiologic results were found in patients who contracted the disease before the age of seven and in whom necrosis was not yet at an advanced stage. The results in children who did not undergo treatment until after the age of eight and those with the disease at Catterall's stage IV were significantly poorer as far as arthrotic deformation of the hip joint was concerned. Radiologic evaluation of the hips examined, with regard to severity of arthrosis, epiphyseal index, and hip value show that the hip value is the best means of distinguishing prearthrotically deformed hip joints from normal findings. For example, at the time of follow-up severe prearthrotic changes were found in 40 of 105 hip joints when the hip values were analyzed. Therefore, in cases of Perthes' disease also, the hip value is of special importance in prognostic counseling of patients as regards the extent to which the hip joint can be subjected to stress either at work or in sports.

[Scintigraphic findings in fracture of the vertebral body]. / Szintigraphische Befunde bei der Wirbelkörperfraktur.

The "region-of-interest technique" was applied for taking 85 quantifying skeleton scintigrams in 60 patients suffering from 75 stable impression fractures of the inferior thoracic spine or the lumbar spine. The skeleton scintigrams were made between 3 days and 6 years after the accident, predominantly between the first and twelfth posttraumatic week. The evaluation curves of the scintigraphic quotients following to fractures of the vertebral bodies show a linear increase of the quotient until the fourth week and afterwards an exponential decrease. The quantifying skeleton scintigraphy is not only valuable in diagnostic evaluation but allows also to assess the age of fractures of the vertebral bodies. In the future, quantifying skeleton scintigraphy may thus play an important role in the examination of fractures of the vertebral bodies.

[Meniscus transplantation--animal experiment study]. / Die Meniskustransplantation--Tierexperimentelle Untersuchung.

The possibility of repairing meniscus lesions by transplantation was studied in 30 sheep. Grafting of the meniscus was performed in 15 animals each either with lyophilised homologous menisci that had been sterilised by gamma rays, or with deep frozen homologous menisci. 27 menisci could be evaluated over a period of 48 weeks. Besides the clinical, microscopical and scanning electron microscopical evaluation, the grafts were also examined microangiographically and biomechanically. Both lyophilised and deep-freeze menisci are suitable for transplantation, but the processes of transformation of the grafts are significantly different: Whereas complete transformation takes place in the lyophilised transplant during the study period of 48 weeks, the deep-frozen transplant is accepted and heals without any remarkable transformation process to full function. Although the biomechanical stress tests yielded good stress tolerance for both types of transplants, the deep frozen homologous menisci appear to be more favourable with regard to possible clinical aspects since they do not undergo any transformation.

[Long-term results of the tibial head pendulum osteotomy in varus and valgus gonarthrosis in the elderly]. / Langzeitergebnisse der Tibiakopf-Pendelosteotomie bei der Varus-und Valgusgonarthrose des älteren Menschen.

Proximal tibia-head osteotomy is an approved surgical method for the treatment of unilateral knee arthrosis. In a follow-up examination of 44 patients with 56 operated knees the long-term results more than 10 years after surgery are evaluated in older patients with varus and valgus arthrosis. It can be demonstrated that, if the indication is right, excellent long-term results can be expected, also for older patients with unilateral gonarthrosis. A fixation with metal implants seems to be unnecessary, and the complication rate is low.

[Meniscus refixation and transplantation]. / Meniscusrefixation und -transplantation.

The knowledge we have about the biomechanical importance of the menisci of the knee joint makes it imperative, where possible, to treat their injuries by means of meniscus-conserving measures. Hence today meniscal suturing is performed successfully not only in fresh injuries but also in old baseline longitudinal tears, whether by means of the arthroscope or arthrotomy. Even after having removed the medial meniscus at a previous operation this can be replaced through homologous lyophilized or deep-frozen meniscal transplants, as would be applicable in cruciate ligament insufficiency of the knee joint. As such it may act as a mechanical protection, during the postoperative period, for an anterior cruciate ligament transplant.