Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot (talobot)

March 21, 2024 updated by: University Hospital, Montpellier

Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study

This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

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

  • France
    • Herault
      • Montpellier, Herault, France, 34295
        • CHRU Lapeyronie

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

14 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hemiparesis secondary to a lesion of the central nervous system, regardless of the etiology dated within 6 months
  • Orthopedic equine-varus deformity of the foot and ankle requiring surgery
  • Patient able to move by walking preoperatively at least 2 meters with or without technical assistance or may earn postoperative walking ability

Exclusion Criteria:

  • History of foot surgery the side to be operated
  • Significant deformation set foot and ankle (requiring treatment with triple arthrodesis)
  • Bilateral surgery
  • Progressive neurological disease
  • Dystonic movements or movement disorders
  • Realization of a botulinum toxin injection in the 6 months preceding gesture
  • Important cognitive impairment

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arthrodesis talonavicular
arthrodesis talonavicular in addition to tendon gestures
Procedure: arthrodesis talonavicular
Procedure: tendon gestures
Active Comparator: tendon gestures
tendon gestures only
Procedure: tendon gestures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
walking speed at one year
Time Frame: 12 months after surgery intervention
12 months after surgery intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
walking speed at 3 and 6 months
Time Frame: 3 months and 6 months after surgery intervention
3 months and 6 months after surgery intervention

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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 (Actual)

December 1, 2015

Primary Completion (Actual)

June 27, 2023

Study Completion (Actual)

June 27, 2023

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimated)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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