Early Weight Bearing for Ankle Fractures

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

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.

Study Overview

• Status: Completed
• Conditions: Broken Ankle

• Study Type: Observational
• Enrollment (Actual): 19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that present with bimalleolar or trimalleolar ankle fractures

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcome Scores	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.	12 months post operatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Investigators: Principal Investigator: Blake W Miller, DO, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (Estimated): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: 2016-081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO