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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT01129583
First received: May 21, 2010
Last updated: May 2, 2011
Last verified: May 2011
  Purpose

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 Intervention
Post Traumatic Stiffness
Drug: Botulinum Toxin Type A
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: 1 year post-op ] [ Designated as safety issue: No ]

    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:
  • Elbow Range of Motion [ Time Frame: 3 months post-op ] [ Designated as safety issue: No ]
    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.

  • Broberg Morrey Composite Elbow Function Score [ Time Frame: 6 months post-op ] [ Designated as safety issue: No ]
    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).


Enrollment: 18
Study Start Date: November 2003
Study Completion Date: May 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129583

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Allergan
Investigators
Principal Investigator: Melvin Rosenwasser, MD Columbia University
  More Information

No publications provided

Responsible Party: Dr. Melvin P. Rosenwasser, Columbia University
ClinicalTrials.gov Identifier: NCT01129583     History of Changes
Other Study ID Numbers: AAAA8392
Study First Received: May 21, 2010
Results First Received: June 16, 2010
Last Updated: May 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Botulinum Toxin
Elbow Stiffness

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014