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

AO Clinical Investigation and Publishing Documentation3 sites in 1 country47 target enrollmentJanuary 2013

ConditionsCharcot Neuroarthropathy Diabetic Foot

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Charcot Neuroarthropathy
Sponsor: AO Clinical Investigation and Publishing Documentation
Enrollment: 47
Locations: 3
Primary Endpoint: Treatment failure within the first year after surgery
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

May 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AO Clinical Investigation and Publishing Documentation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Treatment failure within the first year after surgery

Time Frame: 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 Outcomes

Immobilization and non-weightbearing(Date of surgery to time of full weightbearing)
Surgery details(Date of surgery)
Adverse events related to the treatment or device under investigation(Date of surgery to 2 years post-op)
Treatment failure within the first two years after surgery(Date of surgery to 2 years post-op)
Foot angles(Pre-op, post-op, 6w, 12w, 6m, 12m)