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

Completed · Not applicable

Conditions studied: Post Traumatic Stiffness

In brief

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.

Key facts

Study ID

NCT01129583

Run by

Columbia University

People needed

18

Starts

2003-11-01

Expected to finish

2010-05-01

Last updated by the study team

2015-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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