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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01770639
First received: January 16, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Charcot Neuroarthropathy
Diabetic Foot
Procedure: MFB

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Treatment failure within the first year after surgery [ Time Frame: Date of surgery to 1 year posto-op ] [ Designated as safety issue: Yes ]
    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:
  • Treatment failure within the first two years after surgery [ Time Frame: Date of surgery to 2 years post-op ] [ Designated as safety issue: Yes ]
    The occurrence and the date of a secondary surgical intervention for correction of deformity or an amputation within the first two years after surgery.

  • Adverse events related to the treatment or device under investigation [ Time Frame: Date of surgery to 2 years post-op ] [ Designated as safety issue: Yes ]
    The occurrence, type, and date of adverse events related to the midfoot arthrodesis or the MFB within the first two years after surgery.

  • Immobilization and non-weightbearing [ Time Frame: Date of surgery to time of full weightbearing ] [ Designated as safety issue: No ]
    The duration and type of postoperative immobilization and the duration of postoperative non-weightbearing.

  • Surgery details [ Time Frame: Date of surgery ] [ Designated as safety issue: No ]
    Technical details of the midfoot reconstruction surgery .

  • Foot angles [ Time Frame: Pre-op, post-op, 6w, 12w, 6m, 12m ] [ Designated as safety issue: No ]
    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.


Enrollment: 47
Study Start Date: January 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770639

Locations
Germany
Universitätsklinikum Dresden
Dresden, Germany
Universität Rostock
Rostock, Germany
Klinik für Fuss und Sprunggelenkchirurgie Rummelsberg
Rummelsberg, Germany
Sponsors and Collaborators
AO Clinical Investigation and Documentation
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01770639     History of Changes
Other Study ID Numbers: MFB Retro
Study First Received: January 16, 2013
Last Updated: June 24, 2014
Health Authority: Germany: Ethics Commission
Sweden: Regional Ethical Review Board

Keywords provided by AO Clinical Investigation and Documentation:
charcot foot
charcot neuroarthropathy
midfoot arthrodesis
midfoot fusion

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on September 18, 2014