Is Deltoid Ligament Repair for Ankle Fracture Necessary?

NCT ID: NCT02863042

Last Updated: 2018-08-22

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-08-20

Brief Summary

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The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.

Detailed Description

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The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.

Conditions

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Ankle Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deltoid Tendon Repaired

Repair Deltoid Tendon

Group Type EXPERIMENTAL

Repair Deltoid Tendon

Intervention Type PROCEDURE

Ankle Fracture Without Deltoid Tendon Repair

Group Type OTHER

Ankle Fracture Without Deltoid Tendon Repair

Intervention Type OTHER

Standard of care

Interventions

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Repair Deltoid Tendon

Intervention Type PROCEDURE

Ankle Fracture Without Deltoid Tendon Repair

Standard of care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Supination-external rotation ankle fracture with deltoid ligament incompetency
* Minimum of 2 year clinical follow up

Exclusion Criteria

* Non-supination-external rotation ankle fracture
* Medial malleolus fracture
* Incomplete clinical or radiographic followup.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Glenn G. Shi, M.D.

Orthopedic Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Glenn G Shi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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16-003179

Identifier Type: -

Identifier Source: org_study_id

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