Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot

NCT ID: NCT02790346

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2023-06-27

Brief Summary

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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.

Detailed Description

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Conditions

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Orthopedic Equine Varus Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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arthrodesis talonavicular

arthrodesis talonavicular in addition to tendon gestures

Group Type EXPERIMENTAL

arthrodesis talonavicular

Intervention Type PROCEDURE

tendon gestures

Intervention Type PROCEDURE

tendon gestures

tendon gestures only

Group Type ACTIVE_COMPARATOR

tendon gestures

Intervention Type PROCEDURE

Interventions

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arthrodesis talonavicular

Intervention Type PROCEDURE

tendon gestures

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Lapeyronie

Montpellier, Herault, France

Site Status

Countries

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France

Other Identifiers

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9547

Identifier Type: -

Identifier Source: org_study_id

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