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

June 24, 2014 updated by: AO Clinical Investigation and Publishing Documentation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany
        • Universitätsklinikum Dresden
      • Rostock, Germany
        • Universität Rostock
      • Rummelsberg, Germany
        • Klinik für Fuss und Sprunggelenkchirurgie Rummelsberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MFB
Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)
Procedure: MFB
Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 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.
Date of surgery to 2 years post-op
Adverse events related to the treatment or device under investigation
Time Frame: 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.
Date of surgery to 2 years post-op
Immobilization and non-weightbearing
Time Frame: Date of surgery to time of full 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
Time Frame: Date of surgery
Technical details of the midfoot reconstruction surgery .
Date of surgery
Foot angles
Time Frame: 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.
Pre-op, post-op, 6w, 12w, 6m, 12m

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFB Retro

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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