CompletedNot Applicable

Botulinum Toxin as a Novel Treatment for Prevention of Post-Traumatic Elbow Stiffness

United States18 participantsStarted 2003-11

Plain-language summary

This is a randomized double blind placebo controlled study to investigate the hypothesis that injection of botulinum toxin A into the muscles surrounding the elbow following the surgical treatment of an elbow fracture will reduce postoperative stiffness and improve 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: * Capable of providing informed consent * 18 years old and older * Elbow fractures that require operative intervention including: * Supracondylar distal humerus fractures * Intra-articular distal humerus fractures * Proximal ulna and radius fractures Exclusion Criteria: * Patients less than 18 years old * Injuries that do not normally require surgical repair * Patients with underlying spasticity * Patients with burns about the elbow * Patients with extensive soft tissue injuries of the elbow * Patients with head or spinal cord injuries * Myasthenia gravis, Eaton-Lambert, amyotrophic lateral sclerosis or any other disease that interferes with neuromuscular function * Use of aminoglycoside antibiotics or other drug therapies that interfere with neuromuscular function

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

Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

Timeframe: 1 year post-op

Trial details

NCT IDNCT01129583

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-09

Results submitted2010-06-16

View on ClinicalTrials.gov More Post Traumatic Stiffness 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.