Early Weight Bearing for Ankle Fractures

Completed

• Conditions: Broken Ankle

• Registration Number: NCT02736370
• Lead Sponsor: Spectrum Health Hospitals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-13
• Study Start: 2016-05
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Outcome Scores	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

Name	Time	Method
Return to work	up to 12 months	During follow up visits the patients return to work status will be assessed.
Fracture Healing	up to 12 months	During follow up visits fractures healing will be assessed by physician review of x-rays.
Pain Scores	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.
Post operative complications	up to 12 months	Post operative complications will be assessed during follow up visits.