By InvitationNot Applicable

Early Weight Bearing in Unicondylar Tibial Plateau Fractures

United States60 participantsStarted 2022-12-21

Plain-language summary

The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care). It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome

Who can participate

Age range

18 Years – 65 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: * Adult patients, at least 18 years of age, max 65 years of age * Unilateral tibial plateau fracture AO:41b/c * Written consent to participate (consent can be revoked at any time without giving reasons) * Surgery during the study period * Follow-up on-site (Salt Lake City, Utah, United States) Exclusion Criteria: * Multiple injured or polytraumatized patients * Other injuries or illnesses that impair the patient's mobility or gait * Cognitive limitations such as dementia, delirium or similar disease * Refusal to participate * Severe underlying disease with significant limitations in the ability to regenerate e.g. malignancies * Pathologic or osteoporotic fractures * Unable to attend clinic in person for follow-ups * pregnant women and fetus

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

Average peak load (Newtons (N))

Timeframe: 6 weeks for early mobilization group

Average peak load (Newtons (N))

Timeframe: 10 weeks for standard of care (SOC) group

Average peak load (Newtons (N))

Timeframe: 1 week after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Average peak load (Newtons (N))

Timeframe: 2 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Average peak load (Newtons (N))

Timeframe: 6 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Average peak load (Newtons (N))

Timeframe: 12 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Average peak load (Newtons (N))

Timeframe: 6 months after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Trial details

NCT IDNCT06389240

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12

View on ClinicalTrials.gov More Early Mobilization trials

Plain-language summary

Who can participate

Age range

18 Years – 65 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.

What they're measuring

Average peak load (Newtons (N))

Timeframe: 6 weeks for early mobilization group

Average peak load (Newtons (N))

Timeframe: 10 weeks for standard of care (SOC) group

Average peak load (Newtons (N))

Timeframe: 1 week after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Average peak load (Newtons (N))

Timeframe: 2 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Average peak load (Newtons (N))

Timeframe: 6 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Average peak load (Newtons (N))

Timeframe: 12 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.

Average peak load (Newtons (N))

Timeframe: 6 months after full weight bearing is allowed for both 6 week early mobilization and SOC groups.