TerminatedNot Applicable

Progressive Splinting Status Post Elbow Fractures and Dislocations

Stopped: low accrual

United States17 participantsStarted 2006-09

Plain-language summary

The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.

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: * 18 years of age or older * Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation * Agrees to participate and signs informed consent * English Speaking (outcome questionnaires are validated for English only) Exclusion Criteria: * Less than 18 years of age * Closed Head Injury * Burn Injuries * Ipsilateral upper extremity fracture(s) requiring surgery * Nonunion of prior distal humerus fracture or fracture dislocation * Type 3 open distal humerus fracture dislocation * Insufficient fracture fixation to allow early range of motion * Transient population with no fixed address * Not willing to sign informed consent * Does not speak English

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

Elbow ROM at 12 Months

Timeframe: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively

Trial details

NCT IDNCT00580866

SponsorVanderbilt University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-07

Results submitted2015-11-10

View on ClinicalTrials.gov More Upper Extremity Fracture trials

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.