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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770639
• Other study ID #: MFB Retro
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: June 24, 2014
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionSweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Charcot Neuroarthropathy
• Diabetic Foot

Intervention

Procedure:
• MFB
Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)

Locations

Country	Name	City	State
Germany	Universitätsklinikum Dresden	Dresden
Germany	Universität Rostock	Rostock
Germany	Klinik für Fuss und Sprunggelenkchirurgie Rummelsberg	Rummelsberg

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Surgery details	Technical details of the midfoot reconstruction surgery .	Date of surgery	No
Secondary	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	No