Intraoperative Injection of Botulinum Toxin A (Botox) for the Prevention of Post-Traumatic Elbow Stiffness: A Randomized Double Blind Placebo Controlled Study
Overview
- Phase
- N/A
- Intervention
- Botulinum Toxin Type A
- Conditions
- Post Traumatic Stiffness
- Sponsor
- Columbia University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
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
Arms & Interventions
Botulinum Toxin
100 U injected into biceps, 100 U into brachialis
Intervention: Botulinum Toxin Type A
Saline
100 U injected into biceps, 100 U into brachialis
Intervention: Saline
Outcomes
Primary Outcomes
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 Outcomes
- Elbow Range of Motion(3 months post-op)
- Broberg Morrey Composite Elbow Function Score(6 months post-op)