Early Weight Bearing for Ankle Fractures

NCT ID: NCT02736370

Last Updated: 2023-09-22

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

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-02-28

Brief Summary

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The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.

Detailed Description

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Conditions

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Broken Ankle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Men and women ages of 18 and up
* Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures
* Orthopaedic Trauma Association (OTA) classification of 44A and 44B
* English speaking
* Able and willing to consent

Exclusion Criteria

* Open fractures
* OTA classification of 43 and 44C
* Patients with diabetes mellitus
* No other lower extremity injuries that would affect functional outcomes
* Previous use of walking aides
* Patients with paralysis or hemiplegia
* Ankle fractures requiring syndesmotic repair
* Ankle fractures requiring fixation of the posterior malleolar
* Associated neurovascular injury
* Problems maintaining follow up (homeless or not willing to return for follow up)
* Pathological fractures
* Prisoners
* Patients not allowed to bear weight before the 6 week post-operative follow up visit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blake W Miller, DO

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Other Identifiers

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2016-081

Identifier Type: -

Identifier Source: org_study_id

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