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Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 162 - 162
1 Mar 2009
Gollwitzer H Diehl P von Korff A Schauwecker J Gerdesmeyer L
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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.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 56 - 56
1 Mar 2009
Diehl P Dörfler F Gradinger F Gradinger R Rechl H
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Goal: Evaluation of prognostic factors on the long term survival of soft tissue sarcomas after resection.

Methods: Between 1991–2003

a) 29 synovial sarcomas males:femals 15:14 (mean age 36),

b) 15 leiomyosarcomas m:f 8:7 (mean age 62) and between 1997–2004

c) 26 malignant fibrous histiocytoma MFH m:f 11:15 (mean age 69) cases were treated individually with multimodal therapy regimen (irradiation/chemotherapy).

R0 resection was archived by 71% of the synovialsarcomas, 60% of leiomyosarcomas and 73% of MFHs’. The histological garding of synovialsarcomas was: G1: 0%, G2:21%, G3:73% and Gx: 6%. The histological garding of leiomyosarcomas was: G1:7%, G2:20%, G3:73% with 11 primary recurrences and the grading of the MFHs’ was G1: 7,7%, G2: 15,4%, G3: 69,2% und Gx: 7,7%.

Results:

Synovial sarcomas:

After a follow-up of 8 (2–14) years the overall survival was 57%, after R0-resection 65% and after R1 resection 0%. The survival of G2 und G3 was 67% and 53% respectively. The survival of T1 and T2-tumors was 100% and 39% respectively. The 2- and 4 year survival of patients with primary metastases and local recurrence was 50% und 28%. 55% of the patients developed local recurrence.

Leiomyosarcomas

After a follow-up of 8 (2–14) years the overall survival was 33%, after R0-resection 44% and after R1 resection 17%. The survival of G2 und G3 was 33% and 27% respectively. The survival of T1 and T2-tumors was 50% and 33% respectively. The 2- and 4 year survival of patients with primary metastases and local recurrence was 73% und 32%. 80% of the patients developed local recurrence.

MFHs’

After a follow-up of 4,5 (1–8) years the overall survival was 73%, after R0-resection 90% and after R1 resection 50%. The survival of G1, G2 und G3 was 50%, 75% and 83% respectively. The survival of T1 and T2-tumors was 100% and 75% respectively. The 2- and 4 year survival of patients with primary metastases and local recurrence was 20% und 0%. 19% of the patients developed local recurrence.

Scores for function and quality of life after treatment were 79% (37%–100%) for synovial- and 76% (53%–93%) for leiomyosarcomas and 76% (44%–100%) for MFHs

Conclusions: The investigated soft tissue sarcomas are highly malignant tumors. Bad prognostic factors for reduced long term survival are T2-tumors and G3-tumors (except MFHs’), local recurrence, metastases at the time of diagnosis and tumors after R1-resection, requiring aggressive multimodal treatment with chemotherapy, radiation and wide or even radical surgery.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 191 - 191
1 Mar 2006
Diehl P Magdolen U Schauwecker J Eichelberg K Gollwitzer H Gradinger R Mittelmeier W Schmitt M
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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.