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

Primary Purpose

Orthopedic Equine Varus Deformity

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
arthrodesis talonavicular
tendon gestures
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Equine Varus Deformity focused on measuring hemiparesis, deformity of the foot and ankle

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU Lapeyronie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

arthrodesis talonavicular

tendon gestures

Arm Description

arthrodesis talonavicular in addition to tendon gestures

tendon gestures only

Outcomes

Primary Outcome Measures

walking speed at one year

Secondary Outcome Measures

walking speed at 3 and 6 months

Full Information

First Posted
May 17, 2016
Last Updated
May 16, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02790346
Brief Title
Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot
Acronym
talobot
Official Title
Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2015 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Equine Varus Deformity
Keywords
hemiparesis, deformity of the foot and ankle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arthrodesis talonavicular
Arm Type
Experimental
Arm Description
arthrodesis talonavicular in addition to tendon gestures
Arm Title
tendon gestures
Arm Type
Active Comparator
Arm Description
tendon gestures only
Intervention Type
Procedure
Intervention Name(s)
arthrodesis talonavicular
Intervention Type
Procedure
Intervention Name(s)
tendon gestures
Primary Outcome Measure Information:
Title
walking speed at one year
Time Frame
12 months after surgery intervention
Secondary Outcome Measure Information:
Title
walking speed at 3 and 6 months
Time Frame
3 months and 6 months after surgery intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHRU Lapeyronie
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot

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