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

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

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 Overview

• Status: Terminated
• Conditions: Diabetes Mellitus 1 or 2; Midfoot Charcot Neuroarthropathy
• Intervention / Treatment: Procedure: Surgery with Midfoot Fusion Bolt; Procedure: Cast treatment

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midfoot Fusion Bolt	Procedure: Surgery with Midfoot Fusion Bolt; Surgery with Midfoot Fusion Bolt
Experimental: Cast treatment	Procedure: Cast treatment; Cast treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment failure rate	Treatment failure is defined as the occurrence of one or more of the following: Amputation; Occurrence of ulcer or worsening of existing ulcer (according to Wagner classification); Surgical intervention for correction of deformity after initial treatment	baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot function	Foot and ankle ability measure score and standard Range of motion measurements.	baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Radiologic outcome	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.	baseline, 12 weeks, 12 months
Evaluation of the generic quality of life including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression	EuroQoL5 questionnaire	baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Rate of complications		baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Foot temperature	Diabetica Solutions thermometer	baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 3, 2010

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Sella and Barrete Stage 0 1 or 2
• Other Study ID Numbers: MFB 2010