NCT01079637

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

Midfoot Fusion Bolt (MFB). A Randomized Controlled Multicenter Study to Assess the Effectiveness of Surgical Treatment With Midfoot Fusion Bolt in the Early Stage of Diabetic-neuropathic Charcot Feet

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus 1 or 2
• Midfoot Charcot Neuroarthropathy

Interventions

Type	Name	Description
PROCEDURE	Surgery with Midfoot Fusion Bolt	Surgery with Midfoot Fusion Bolt
PROCEDURE	Cast treatment	Cast treatment

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-03-03
• Last updated: 2021-07-28

Locations

1 site across 1 country: Germany