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

AO Clinical Investigation and Publishing Documentation

Status

Terminated

Conditions

Diabetes Mellitus 1 or 2

Midfoot Charcot Neuroarthropathy

Treatments

Procedure: Cast treatment

Procedure: Surgery with Midfoot Fusion Bolt

Study type

Interventional

Funder types

Other

Identifiers

NCT01079637

MFB 2010

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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