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

Sponsor:	AO Clinical Investigation and Documentation
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT01079637

Purpose

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.

Condition	Intervention
Diabetes Mellitus 1 or 2 Midfoot Charcot Neuroarthropathy	Procedure: Surgery with Midfoot Fusion Bolt Procedure: Cast treatment

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Foot Health

U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:

treatment failure rate [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

Foot function [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
Foot and ankle ability measure score and standard Range of motion measurements.
Radiologic outcome [ Time Frame: baseline, 12 weeks, 12 months ] [ Designated as safety issue: No ]
Weightbearing or simulate lateral and AP x-Rays of both feet will be taken. Talus-first metatarsal and Calcaneus-fifth metatarsal angle will be measured.
Quality of life [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
EuroQoL5 questionnaire
Rate of complications [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
Foot temperature [ Time Frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
Diabetica Solutions thermometer

Estimated Enrollment:	116
Study Start Date:	May 2010
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Midfoot Fusion Bolt: Experimental	Procedure: Surgery with Midfoot Fusion Bolt Surgery with Midfoot Fusion Bolt
Cast treatment: Experimental	Procedure: Cast treatment Cast treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079637

Contacts

Contact: Maja Schlittler, MSc

0041 44 200 24 55

maja.schlittler@aofoundation.org

Locations

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

Sponsors and Collaborators

AO Clinical Investigation and Documentation

More Information

No publications provided

Responsible Party:	Sophiahemmet, Stockholms Fotkirurgklinik, Valhallavägen 91, 11486 Stockholm, Sweden ( Dr. Per-Henrik Agren )
ClinicalTrials.gov Identifier:	NCT01079637 History of Changes
Other Study ID Numbers:	MFB 2010
Study First Received:	March 1, 2010
Last Updated:	March 2, 2010
Health Authority:	Switzerland: Swissmedic

Keywords provided by AO Clinical Investigation and Documentation:

Sella and Barrete Stage 0 1 or 2

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 01, 2010