TerminatedPhase 3

The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

Stopped: Inadequate recruitment.

Canada20 participantsStarted 2010-04

Plain-language summary

Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored. Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement

Who can participate

Age range

17 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: * Skeletally mature * Trauma patients with single-system musculoskeletal injuries. * Proximal tibia fractures treated with open reduction and internal fixation. * Unilateral proximal tibial injuries. Exclusion Criteria: * Previous ipsilateral knee surgery * Upper extremity injuries impairing mobilization * Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury * Associated injuries impairing mobilization * Suspected or confirmed compartment syndrome * Open fractures * Patients previously on narcotics * Patients with impaired sensorium Concurrent head injury Intoxication

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

Cost

Timeframe: 3 months

Trial details

NCT IDNCT01104831

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Proximal Tibia Fracture trials