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Midfoot Fusion Bolt (MFB) in the Early Stage of Diabetic-neuropathic Charcot Feet

2014-08-27 03:15:30 | BioPortfolio

Summary

Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis with MFB against cast treatment in patients suffering from early stage Charcot neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2 years after initial treatment. Treatment failure is defined as the occurrence of one or more of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3. Surgical intervention for correction of deformity after initial treatment. The secondary aims are to compare foot function, radiologic outcome, quality of life, complications and foot temperature between the two groups.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Mellitus 1 or 2

Intervention

Surgery with Midfoot Fusion Bolt, Cast treatment

Location

Dept. of Trauma and Reconstructive Surgery, University of Rostock
Rostock
Germany
18055

Status

Not yet recruiting

Source

AO Clinical Investigation and Documentation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:30-0400

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Medical and Biotech [MESH] Definitions

The GENETIC RECOMBINATION of the parts of two or more GENES resulting in a gene with different or additional regulatory regions, or a new chimeric gene product. ONCOGENE FUSION includes an ONCOGENE as at least one of the fusion partners and such gene fusions are often detected in neoplastic cells and are transcribed into ONCOGENE FUSION PROTEINS. ARTIFICIAL GENE FUSION is carried out in vitro by RECOMBINANT DNA technology.

Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).

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The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

The GENETIC RECOMBINATION of the parts of two or more GENES, including an ONCOGENE as at least one of the fusion partners. Such gene fusions are often detected in neoplastic cells and are transcribed into ONCOGENE FUSION PROTEINS.

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