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The study was stopped because there were not enough eligible patients to complete the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midfoot Fusion Bolt | Experimental |
| |
| Cast treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery with Midfoot Fusion Bolt | Procedure | Surgery with Midfoot Fusion Bolt |
| |
| Measure | Description | Time Frame |
|---|---|---|
| treatment failure rate | Treatment failure is defined as the occurrence of one or more of the following:
| baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Trauma and Reconstructive Surgery, University of Rostock | Rostock | 18055 | Germany |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Cast treatment |
| Procedure |
Cast treatment |
|
| 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 |