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

AO Clinical Investigation and Publishing Documentation1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus 1 or 2 Midfoot Charcot Neuroarthropathy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years * Patients with Diabetes Mellitus Type I or II * CN stages 0, 1 or 2 of the midfoot (Sella and Barrette classification) * Willingness and ability to participate in the study follow-up according to the protocol * Ability to understand and read local language at elementary level * Signed informed consent Exclusion Criteria: * Legal incompetence * Previous Charcot foot on the affected side * Active osteomyelitis in the affected foot * Above knee amputation on the contralateral side * Patient health status not adequate for surgery * Active malignacy * Severe peripheral arterial disease (ankle-brachial index \<0.7 or absent digital waveforms on Doppler) * Ulcer grade 2 or more on the Wagner classification system * Alcohol or drug abuse * Life-threatening co-morbidities

Outcomes

Primary Outcomes

treatment failure rate

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 (according to Wagner classification) 3. Surgical intervention for correction of deformity after initial treatment