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Trial record 1 of 1 for:    Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures
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Early Weight Bearing for Ankle Fractures

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ClinicalTrials.gov Identifier: NCT02736370
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2016
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Spectrum Health Hospitals

Study Description
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Brief Summary:
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.

Condition or disease
Broken Ankle

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures Without Syndesmotic Disruption
Study Start Date : May 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Functional Outcome Scores [ Time Frame: 12 months post operatively ]
    During follow up visits functional outcomes scores will be assess using the Foot and Ankle Score and the PROMIS (Patient Reported Outcomes Measurement Information System) Mobility Measure questionnaires. These forms will be analyzed together to determine the patients functional outcomes.


Secondary Outcome Measures :
  1. Return to work [ Time Frame: up to 12 months ]
    During follow up visits the patients return to work status will be assessed.

  2. Fracture Healing [ Time Frame: up to 12 months ]
    During follow up visits fractures healing will be assessed by physician review of x-rays.

  3. Pain Scores [ Time Frame: 12 months post operatively ]
    Pain Scores and PROMIS Pain Intensity and Interference questionnaires will be assessed during follow up. These forms will be analyzed together to determine the patients overall pain.

  4. Post operative complications [ Time Frame: up to 12 months ]
    Post operative complications will be assessed during follow up visits.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that present with bimalleolar or trimalleolar ankle fractures
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736370


Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: Blake W Miller, DO Spectrum Health Hospitals
More Information
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Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02736370    
Other Study ID Numbers: 2016-81
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ankle Fractures
Fractures, Bone
Wounds and Injuries