Introduction: Surgical treatment options of malignant tumors of the pelvis were traditionally very limited, and often resulted in an amputation. With development of neo/-adjuvant therapies, limb-salvage surgery has become the treatment of choice. Still, the treatment remains challenging, and options for pelvic reconstruction after resection such as allografts, radiated autografts, saddle-prosthesis, custom made prosthesis and modular reconstruction systems are all associated with high complication rates. Aim of our retrospective study was to evaluate the results after reconstruction of the pelvis with a custom-made pelvic megaprosthesis.

Materials and Methods: From 1977 to 2008, a total of 92 patients with malignant tumors or metastases of the pelvis were treated by resection and reconstruction with custom-made pelvic megaprostheses at our institution. Mean age was 56.2 years [17–77] with 43 male patients and 59 female. We treated 45 primary tumors and 47 metastases. Primary tumors included chondrosarcoma (45,4%), Ewing’s sarcoma (18,2%), malignant fibrous histiocytoma (9,1%), osteosarcoma (4,5%) and others. In the group with metastases we found renal cell carcinoma (52,4%), mamma-carcinoma (14,3%), thyroid carcinoma (9,5%), oropharyngeal carcinomas (9,5%), and others. Wide resection was performed in 11 patients, marginal-resection in 47, and intralesional-resection in 34 patients. Depending on the bone defect after tumor resection, pelvic megaprostheses were implanted either in the superior part of the iliac wing, the sacrum and/or the lower lumbar spine.

Results: Patients were reassessed repeatedly at two different time points resulting in a mean follow-up of 3,6 years [range 0,5 to 8,4years]. A total of 55 patients were available for follow-up, 29 had died and 6 Patients were not available for evalutation (living abroad). In the group with malignant tumors 50% of the patients were alive after 5 years; 50% of patients with metastasis survived at least 2 years. The local recurrence rate was 15%. In 2 of these patients local re-resection was possible, and 5 patients were treated with secondary external hemi-pelvectomy. Aseptic failure of the megaprosthesis was observed in 3%. The MSTS-Score showed good results in 34%, fair results in 42% and poor results in 23%. We found infections in 14%. Nerve palsy occurred in 11%, thombosis in 5%, and dislocation of the prosthesis in 15% of patients.

Discussion: Our study demonstrates that reconstruction of pelvic bone defects after tumor resection with custom-made megaprosthesis allows limb-salvage surgery with satisfying functional results. In spite of the relatively high complication rates-which are comparable or even favorable to other reconstruction techniques-we consider the custom-made megaprosthesis our treatment of choice to reconstruct pelvic bone defects.

Background: A total hip arthroplasty system with 3-dimensional interconnecting surface topography was developed for optimum osseous integration and long term stability. The present study was performed to assess long-term implant survival and function.

Methods: We prospectively studied a consecutive series of 100 cementless total hip arthroplasties in 94 patients using the ESKA GHE cementless spongy metal hip replacement. Study end-point was implant revision, and both function as well as satisfaction with treatment outcome was assessed after a mean follow-up of 18 years.

Results: Mean age at the time of operation was 47 years [range 18–65]. Seven patients were lost to follow-up. 11 patients had died for unrelated reasons at 14.1 ± 4.3 years after surgery with all 14 hip replacements in situ. Consequently, at a mean follow-up of 18 years [15.3 – 20.3], 74 patients (74 hips) could be included in the final analysis. Survival with aseptic loosening as the endpoint was 95% for the femoral component and 85% for the acetabular component. Two cups had to be revised for recurrent dislocation, resulting in a total implant survival at follow-up of 95% for the femoral component and 81% for the acetabular component.

Very good functional results were obtained with an improvement of the mean Merle d’Aubigné score from 9.5 ± 2.0 at baseline to 15.0 ± 3.1 at follow-up, and 86% excellent or good results (McNab score). Satisfaction with treatment outcome was high, and 96% of patients would recommend the performed procedure to a friend.

Conclusion: Excellent survival rates were observed in a young patient population after cementless hip arthroplasty with the GHE spongy metal hip replacement at a mean follow-up of eighteen years. Thus, modern cementless hip replacement shows long-term survival and might be favourable in young and active patients.

Context: Published data on extracorporeal shock wave therapy (ESWT) for heel pain provide controversial evidence about the clinical effectiveness. In previous studies, three interventions of ESWT without local anaesthesia demonstrated excellent outcome.

Objective: To give confirmatory proof of effectiveness and safety of focused ESWT administered without local anaesthesia in the treatment of chronic painful heel syndrome.

Design and Participants: Prospective, double-blind, randomized, placebo-controlled multicenter FDA trial conducted among 250 patients.

Interventions: ESWT (0.25 mJ/mm²) or placebo. Both groups received three interventions of 2000 shock wave impulses, each session 1 week apart.

Main Outcome Measures: The primary outcome was the percentage change of heel pain quantified by VAS composite score, as well as the change of Roles and Maudsley score at 12 weeks after the last intervention compared to baseline. Secondary endpoints were defined as single success rates (more than 60% reduction of morning pain, pain at daily activities, and pain with force-meter), overall success rate, physician’s judgment of effectiveness; patient’s satisfaction with outcome, patient’s willingness to recommend treatment, and subject’s analgesic medication consumption.

Results: Follow-up was excellent with 246 patients (98.4%) available for intention-to-treat analysis at 12-week follow-up. ESWT resulted in a 69.2% reduction of heel pain regarding the primary endpoint VAS composite score compared to baseline, compared to 34.5% for placebo (p=0.0027, one-sided). ESWT was also significantly superior to placebo for the Roles and Maudsley score (p=0.0006, one-sided). The combined overall result of the eight secondary criteria also showed statistical significance (P = 0.0015 one-sided, multivariate directional Wilcoxon-Mann-Whitney test). No clinically relevant device-related adverse events were recorded.

Conclusion: The results of the present study provide confirmatory proof of effectiveness of ESWT without local anaesthesia in the treatment of refractory painful heel syndrome.

Introduction: Influence of beta-blockers against fracture is controversial. Role of beta-blockers in fracture treatment not explored.

Objective: to analyze influence of propranolol, a beta-blocker, on fracture healing in a mouse model.

Materials and Methods: Fracture and intramedullary nailing on right femur of 8 week, male C57BL/6 mice. Daily propranolol in drinking water: 0 (control), 4 (low dose) and 20 (high dose) mg/kg 3 week: microcomputed tomography (microCT), histological analyses 6 week: microCT, mechanical testing N = 5 üC 9/group Statistics: two-way ANOVA. Á = 0.05.

Results: From 3 to 6 weeks, callus volume and bone mineral content (BMC) decreased, and tissue mineral density increased significantly in control groups. Callus volume and BMC decreased significantly in low dose groups. No significance in high dose groups. No significance with treatment. At 3 weeks, callus area and woven bone percentage not different with treatment. At 6 weeks, ultimate torque not different with treatment or fracture. Within the control groups, twist at ultimate torque significantly lower in fractured bones. Torsional rigidity increased significantly in fractured bones, but not different with treatment.

Discussion: Most studies based on population observation or manipulation of sympathetic signaling using intact animal bones. The current fracture model may have created neural damage, thereby interrupting the sympathetic pathway and negating its regulation of bone metabolism. Whether neural signaling is compromised by fracture treatment requires further study and may be critical to the action of beta-blockers in bone.

Introduction: The extracorporeal shock wave therapy (ESWT) has a wide spectrum of indication in orthopaedics. However, infection in the application area is regarded as a contraindication. Therefore, in this study, the effect of of ESW on bacteria and their interaction with antibiotics is tested.

Methods: Standardized suspensions of S. aureus (ATCC25923) were exposed to different energy flux densities (EFD 0,38–0,96 mJ/mm²) and different impulse quantities (1000–12000 impulses) of a focussed ESWT. The surviving bacteria were quantified and compared to an untreated control group. The permeability of the cell wall of treated bacteria was analysed with a fluorescence assay and the DNA examined qualitatively for defects.

The influence of ESW on the effectiveness of antibiotics was examined using Gentamicin whose stability under influence of ESW was proven infrared-spectrometrically earlier.

S. aureus in specific broth (CAMHB) was treated with 4000 impulses at 0.59 mJ/mm². Then the MIC against Gentamicin was compared with the MIC of an untreated control group.

For the examination of synergistic effects between antibiotics and ESW, bacteria were treated with ESW (4000 impulses, 0.59 mJ/mm²) in a solution of CAMHB and varying Gentamicin concentrations (0.25 – 4 μ g/ml).

The vital bacteria were quantified and compared to the control group which was exposed to either ESW or Gentamicin. Bacterium colonies were quantified according to the guidelines of the NCCLS, the statistical evaluation was done with the Man-Whitney-U- test.

Results: The ESW showed a significant germicidal effect (P < 0.01) after application of either a high EFD (> 0.60 mJ/mm², 4000 impulses) or a high impulse quantitiy at low EFD (up to 12,000 impulses, < 0.60 mJ/mm²). The amount of CFU could be reduced by up to 99.9%.

Despite the germicidal effect of the ESWT neither a change of the bacterium cell permeability nor a damage to the DNA could be proved. Synergistic effects between Gentamicin and ESW were not found. No loss of effectivity of the Gentamicins at a simultaneous application of the ESW (P > 0.05) could be seen either.

Conclusion: The ESWT has a significant germicidal effect on bacteria after exceeding a certain threshold energy.

It could be shown that the applied total energy is responsible for the germicidal effect rather than single paramters as EFD and impulse quantity. A synergistic effect of antibiotics applied in addition to the ESW could not be proved. When ESW was carried out in presence of Gentamicin, the antibacterial effect of Gentamicin was influenced neither positively nore negatively.

The simultaneous application of ESW and systemically or locally applied antibiotics could represent a new therapy approach against tissue and bone infections. To prove this, further in-vivo studies are needed.

Context: Published data on extracorporeal shock wave therapy (ESWT) for chronic plantar fasciitis provide controversial evidence about the clinical relevance and effectiveness. Treatment parameters have significant influence on outcome and optimal treatment protocols have to be determined.

Objective: To assess the effect size and safety of ESWT compared to placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device and an optimized protocol.

Design, Setting, and Participants: Prospective, double-blind, randomized, placebo-controlled trial conducted among 40 patients. Interventions: ESWT (0.25 mJ/mm²) or placebo without anesthesia. Both groups received 3 treatments of 2000 shock wave impulses, each session 1 week apart. Main Outcome Measures: The primary outcome was the percentage change of heel pain quantified by VAS composite score 12 weeks after the last intervention compared to baseline. Secondary endpoints were defined as changes of single VAS scores (morning pain, pain at daily activities and pain with force-meter application), success rates and changes in Roles and Maudsley score.

Results: ESWT resulted in a 73.2% reduction of heel pain regarding the primary endpoint VAS composite score compared to baseline, being 32.7% superior to placebo. Effect size reached clinical relevance (Mann-Whitney effect size (MW) = 0.6737; 0.6400 being the benchmark for medium-sized, relevant superiority, p = 0.0302 single-sided). With regard to the percentage changes of the single VAS scores and the Roles and Maudsley score, the effect size denoted relevant superiority of the ESWT as well (all MWs ≥ 0.6400). No relevant adverse events occurred.

Conclusion: The results of the present study advocate ESWT for refractory painful heel syndrome demonstrating clinically relevant effect sizes. Specific treatment protocols with proven effectiveness ought to be used in the clinical setting.

Introduction: Extracorporeal shock wave therapy (ESWT) covers a multitude of different indications in modern orthopedics, however, bacterial infections are still considered as contraindications. The goal of the present study was to determine the effect of ESWT on growth of clinically relevant bacteria in orthopedic and trauma surgery.

Methods: Standardised suspensions of a methicillin sensitive and a methicillin resistant strain of Staphylococcus aureus, and reference strains of Staphylococcus epidermidis, Pseudomonas aeruginosa and Enterococ-cus faecalis were subjected to 4000 impulses of high-energy shock waves with an energy flux density (EFD) of 0.96 mJ/mm2 and a frequency of 2 Hz. Furthermore, corresponding suspensions of S. aureus ATCC 25923 were exposed to different impulse rates of shock waves (1000 to 6000 impulses) and to different EFDs up to a maximum of 0.96 mJ/mm2 (2 Hz) to evaluate the influence of shock wave parameters. Subsequently, viable bacteria were quantified by culture and compared with an untreated control.

Results: A highly significant antibacterial effect of the ESWT was demonstrated for all bacterial strains with a reduction of growth to values between 1,1% and 29,7% (P < 0.01). Reference strains of S. aureus and S. epidermidis reacted most sensitive whereas E. faecium demonstrated highest resistance against high-energy shock waves. After applying different energy levels to S. aureus, a significant bactericidal effect was observed only with a minimum threshold EFD of 0.59 mJ/mm2 (P < 0.05). A threshold impulse rate of more than 1000 impulses could be defined to reduce bacterial growth of S. aureus (P < 0.05). Further elevation of energy and impulse rate exponentially increased bacterial killing.

Conclusions: ESWT proved to exert significant antibacterial effect in an energy-dependent manner. The results suggest that infections are not necessarily contraindications to shock wave therapy and could even represent a new indication for ESWT. However, clinical relevance should be assessed in vivo in an animal model.

In orthopedic surgery, sterilization of bone used for reconstruction of osteoarticular defects caused by malignant tumors is carried out in different ways. At present, to devitalize tumor-bearing osteochondral segments, mainly extracorporal irradiation or autoclaving is used. Both methods have substantial disadvantages, e.g. loss of biomechanical and biological integrity of the bone. In particular integration at the autograft-host junction after reimplantation is often impaired due to alterations of the osteoinductivity following irradiation or autoclaving. As an alternative approach, high hydrostatic pressure (HHP) treatment of bone is a new technology, now being used in preclinical testing to inactivate tumor cells without alteration of biomechanical properties of bone, cartilage and tendons. The aim of this study was to investigate the influence of HHP on fibronectin (FN), vitronectin (VN), and type I collagen (col. I) as major extracellular matrix proteins of bone tissue, accountable among others for the osteoinductive properties of bone.

Fibronectin, vitronectin and type I collagen were subjected to HHP (300 and 600 MPa) prior to the coating of cell culture plates with these pre-treated proteins. Following the biological properties were measured by means of cell proliferation, adherence, and spreading of the human osteosarcoma cell line (Saos-2) and primary human osteoblast-like cells.

Up to 600 MPa all tested matrix proteins did not show any changes, regarding the biological properties adherence, spreading and proliferation.

We anticipate that, in orthopedic surgery, HHP can serve as a novel, promising methodical approach, by damaging normal and tumor cells without alteration of osteoinductive properties, thus facilitating osteointegration of the devitalized bone segment in cancer patients after reimplantation.