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The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MFB | Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MFB | Procedure | Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure within the first year after surgery | The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first year after surgery. | Date of surgery to 1 year posto-op |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure within the first two years after surgery | The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first two years after surgery. | Date of surgery to 2 years post-op |
| Adverse events related to the treatment or device under investigation |
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Inclusion Criteria:
Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation
Exclusion Criteria:
- Prisoner at date of inclusion
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Patients with neuro-osteoarthropathy of the foot or with other neurological impairment in combination with foot deformity who have previously undergone surgical reconstruction of the midfoot with the Midfoot Fusion Bolt.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Dresden | Dresden | Germany | ||||
| Universität Rostock |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26564730 | Derived | Richter M, Mittlmeier T, Rammelt S, Agren PH, Hahn S, Eschler A. Intramedullary fixation in severe Charcot osteo-neuroarthropathy with foot deformity results in adequate correction without loss of correction - Results from a multi-centre study. Foot Ankle Surg. 2015 Dec;21(4):269-76. doi: 10.1016/j.fas.2015.02.003. Epub 2015 Mar 9. |
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The occurrence, type, and date of adverse events related to the midfoot arthrodesis or the MFB within the first two years after surgery. |
| Date of surgery to 2 years post-op |
| Immobilization and non-weightbearing | The duration and type of postoperative immobilization and the duration of postoperative non-weightbearing. | Date of surgery to time of full weightbearing |
| Surgery details | Technical details of the midfoot reconstruction surgery . | Date of surgery |
| Foot angles | Talus-first metatarsal angle and calcaneus-fifth metatarsal angle on the AP and lateral x-rays of the affected foot before surgery, immediately after surgery, 6 weeks, 12 weeks, 6 months, and 12 months after surgery. | Pre-op, post-op, 6w, 12w, 6m, 12m |
| Rostock |
| Germany |
| Klinik für Fuss und Sprunggelenkchirurgie Rummelsberg | Rummelsberg | Germany |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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