Clinical trial NCT01129583: Botulinum Toxin as a Novel Treatment for Prevention of Post-Traumatic Elbow Stiffness
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stiffness
Keywords: Botulinum Toxin
Elbow Stiffness
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2010-05-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
timeFrame: 1 year post-op
Secondary outcomes:
measure: Elbow Range of Motion
timeFrame: 3 months post-op
measure: Broberg Morrey Composite Elbow Function Score
timeFrame: 6 months post-op
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Melvin Rosenwasser, MD
role: PRINCIPAL_INVESTIGATOR
References: