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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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