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

NCT ID: NCT01129583

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2010-05-31

Brief 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.

Detailed Description

This is a randomized double blind placebo controlled prospective study in which botulinum toxin A (Botox®) or normal saline will be intraoperatively injected into the muscles surrounding the elbow following the surgical treatment of an elbow fracture or elbow fracture dislocation.

Eligible patients will be identified by the Principal Investigator in his practice or by fellows and residents from the clinic population and emergency department admissions. After providing informed consent, all subjects will undergo a baseline examination that will include a medical and orthopaedic history, physical examination, and radiographs. The surgical procedure itself will not differ from the standard care for elbow fractures. The only difference is injection of Botox® or normal saline into the muscles of the injured arm. Subjects will undergo post-operative evaluation at various intervals for up to two years. The study and control group will be compared to each other and to contralateral arms in regards to elbow range of motion, patient questionnaire scores (DASH) and an observer-based elbow scoring system (Broberg and Morrey).

Traumatic injury to the elbow resulting in a fracture or fracture/dislocation of the elbow often leads to a stiff elbow with limited function. Posttraumatic elbow stiffness is a common problem that is difficult to manage. The best way to decrease the morbidity is through prevention. An intraoperative injection of Botox® has been effective in treating upper limb spasticity disorders and may prevent the development of elbow stiffness, and decrease the need for future surgery to regain motion.

Conditions

Post Traumatic Stiffness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Botulinum Toxin

100 U injected into biceps, 100 U into brachialis

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

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

Saline

100 U injected into biceps, 100 U into brachialis

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Interventions

Botulinum Toxin Type A

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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

Other Intervention Names

Botox®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Melvin Rosenwasser

Robert E. Carroll Professor of Surgery of the Hand in the Department of Orthopaedic Surgery at the New York-Presbyterian Hospital at the Columbia University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melvin Rosenwasser, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAA8392

Identifier Type: -

Identifier Source: org_study_id