A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy
1 other identifier
observational
47
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 25, 2014
June 1, 2014
1.3 years
January 16, 2013
June 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Treatment failure 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
Date of surgery to 2 years post-op
Immobilization and non-weightbearing
Date of surgery to time of full weightbearing
Surgery details
Date of surgery
Foot angles
Pre-op, post-op, 6w, 12w, 6m, 12m
Study Arms (1)
MFB
Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Universitätsklinikum Dresden
Dresden, Germany
Universität Rostock
Rostock, Germany
Klinik für Fuss und Sprunggelenkchirurgie Rummelsberg
Rummelsberg, Germany
Related Publications (1)
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.
PMID: 26564730DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2013
First Posted
January 18, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 25, 2014
Record last verified: 2014-06