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

NCT01079637 | Terminated

• 1 other identifier: MFB 2010
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sella and Barrete Stage 0 1 or 2

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months

Secondary Outcomes (5)

• Foot function

  baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months

• Radiologic outcome

  baseline, 12 weeks, 12 months

• Evaluation of the generic quality of life including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression

  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

  baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months

Study Arms (2)

Midfoot Fusion Bolt

EXPERIMENTAL

Procedure: Surgery with Midfoot Fusion Bolt

Cast treatment

EXPERIMENTAL

Procedure: Cast treatment

Interventions

Surgery with Midfoot Fusion Bolt PROCEDURE

Surgery with Midfoot Fusion Bolt

Midfoot Fusion Bolt

Cast treatment PROCEDURE

Cast treatment

Cast treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (1)

Dept. of Trauma and Reconstructive Surgery, University of Rostock

Rostock, 18055, Germany

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 28, 2021

Record last verified: 2015-06

Locations

DE (1)