The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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 :
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients that present with bimalleolar or trimalleolar ankle fractures
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
Able and willing to consent
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)
Patients not allowed to bear weight before the 6 week post-operative follow up visit