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

Intraoperative Injection of Botulinum Toxin A (Botox) for the Prevention of Post-Traumatic Elbow Stiffness: A Randomized Double Blind Placebo Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stiffness
• Intervention / Treatment: Drug: Botulinum Toxin Type A; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum Toxin; 100 U injected into biceps, 100 U into brachialis	Drug: Botulinum Toxin Type A; Injection into the biceps brachii and brachialis immediately following the initial fracture surgery; Other Names: Botox®
Placebo Comparator: Saline; 100 U injected into biceps, 100 U into brachialis	Drug: Saline; Injection into the biceps brachii and brachialis immediately following the initial fracture surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire	The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb. The DASH is scored in two components: the disability/symptom questions (30 items, scored 1-5) and the optional high performance sport/music or work section (4 items, scored 1-5). The DASH disability/symptom score (0-100) is calculated by averaging all the scores, subtracting one and multiplying by 25. A score of 0 represents "no disability", while 100 represents "maximum possible disability".	1 year post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elbow Range of Motion	Elbow flexion/extension active range of motion was assessed with the use of a standard goniometer with the center placed over the lateral epicondyle and the arms aligned with the long axis of the humerus and ulna, respectively. Full extension (arm completely straight) is defined as 0 degrees, and peak flexion is measured as the angle formed by the arm and forearm compared to a full straight arm.	3 months post-op
Broberg Morrey Composite Elbow Function Score	Composite elbow function store that takes into account range of motion, stability, strength, and pain. Score ranges from 0 (worse possible function) to 100 (best possible function).	6 months post-op

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Allergan
• Investigators: Principal Investigator: Melvin Rosenwasser, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 21, 2010
• First Submitted That Met QC Criteria: May 21, 2010
• First Posted (Estimate): May 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Botulinum Toxin; Elbow Stiffness
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: AAAA8392