An interventional study of Surgery with Midfoot Fusion Bolt and Cast treatment in Diabetes Mellitus 1 or 2 and Midfoot Charcot Neuroarthropathy, sponsored by AO Clinical Investigation and Publishing Documentation. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by AO Clinical Investigation and Publishing Documentation · Not applicable, Interventional, and Treatment
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 1 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 49 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Procedure: Surgery with Midfoot Fusion Bolt
Procedure: Cast treatment
Surgery with Midfoot Fusion Bolt
Cast treatment
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
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Foot function
Foot and ankle ability measure score and standard Range of motion measurements.
Time frame: 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.
Time frame: 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
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Rate of complications
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Foot temperature
Diabetica Solutions thermometer
Time frame: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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AO Clinical Investigation and Publishing Documentation