A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy

Study Overview
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Brief Summary
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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.

Official Title
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A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy

Conditions
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Charcot Neuroarthropathy, Diabetic Foot

Intervention / Treatment
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* Procedure: MFB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 at date of inclusion Previous surgical reconstruction of the midfoot with Midfoot Fusion Bolt(s) for one of the following indications: Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation Exclusion Criteria: - Prisoner at date of inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MFB<br>Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB) | Procedure: MFB<br>* Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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charcot foot, charcot neuroarthropathy, midfoot arthrodesis, midfoot fusion