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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01129583
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : May 2, 2011
Last Update Posted : March 27, 2015
Information provided by (Responsible Party):
Melvin Rosenwasser, Columbia University

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stiffness Drug: Botulinum Toxin Type A Drug: Saline Not Applicable

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intraoperative Injection of Botulinum Toxin A (Botox) for the Prevention of Post-Traumatic Elbow Stiffness: A Randomized Double Blind Placebo Controlled Study
Study Start Date : November 2003
Actual Primary Completion Date : September 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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 Name: 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

Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: 1 year post-op ]

    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".

Secondary Outcome Measures :
  1. Elbow Range of Motion [ Time Frame: 3 months post-op ]
    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.

  2. Broberg Morrey Composite Elbow Function Score [ Time Frame: 6 months post-op ]
    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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01129583

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Melvin Rosenwasser, MD Columbia University

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, Columbia University Identifier: NCT01129583     History of Changes
Other Study ID Numbers: AAAA8392
First Posted: May 24, 2010    Key Record Dates
Results First Posted: May 2, 2011
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by Melvin Rosenwasser, Columbia University:
Botulinum Toxin
Elbow Stiffness

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents