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

Completed

• Conditions: Charcot Neuroarthropathy; Diabetic Foot
• Interventions: Procedure: MFB

• Registration Number: NCT01770639
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-18
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MFB	MFB	Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)

Primary Outcome Measures

Name	Time	Method
Treatment failure within the first year after surgery	Date of surgery to 1 year posto-op	The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first year after surgery.

Secondary Outcome Measures

Name	Time	Method
Immobilization and non-weightbearing	Date of surgery to time of full weightbearing	The duration and type of postoperative immobilization and the duration of postoperative non-weightbearing.
Surgery details	Date of surgery	Technical details of the midfoot reconstruction surgery .
Adverse events related to the treatment or device under investigation	Date of surgery to 2 years post-op	The occurrence, type, and date of adverse events related to the midfoot arthrodesis or the MFB within the first two years after surgery.
Treatment failure within the first two years after surgery	Date of surgery to 2 years post-op	The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first two years after surgery.
Foot angles	Pre-op, post-op, 6w, 12w, 6m, 12m	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.

Trial Locations

Locations (3)

Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Klinik für Fuss und Sprunggelenkchirurgie Rummelsberg; 🇩🇪 Rummelsberg, Germany

Universität Rostock; 🇩🇪 Rostock, Germany