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

NCT01129583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-03-27

Study results available
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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.

Conditions

  • Post Traumatic Stiffness

Interventions

DRUG

Botulinum Toxin Type A

Injection into the biceps brachii and brachialis immediately following the initial fracture surgery

DRUG

Saline

Injection into the biceps brachii and brachialis immediately following the initial fracture surgery

Sponsors & Collaborators

Principal Investigators

  • Melvin Rosenwasser, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2009-09-30
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129583 on ClinicalTrials.gov