CompletedNot Applicable

Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures

United States435 participantsStarted 2020-01-01

Plain-language summary

The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults ages 18 or older
. Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria:
. bimalleolar fracture requiring fixation of any two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
. bimalleolar equivalent SER4 fractures (lateral malleolus fracture requiring fixation and no medial or posterior malleolus fixation)
. trimalleolar fracture with fixation of at least two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
. Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Study Related Complications Experienced

Timeframe: 12 months

Return to Usual Major Activity and Work Productivity

Timeframe: 12 months

Trial details

NCT IDNCT04028414

SponsorMajor Extremity Trauma Research Consortium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-23

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