Early Weight Bearing for Ankle Fractures

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.

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Key information

Conditions

Broken Ankle Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

Return to work

Time frame: up to 12 months

During follow up visits the patients return to work status will be assessed.
Fracture Healing

Time frame: up to 12 months

During follow up visits fractures healing will be assessed by physician review of x-rays.
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.
Post operative complications

Time frame: up to 12 months

Post operative complications will be assessed during follow up visits.

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures Without Syndesmotic Disruption

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Apr 13, 2016
Registry last updated: Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed