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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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