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

Not Applicable

Completed

Conditions: Post Traumatic Stiffness

Interventions: Drug: Botulinum Toxin Type A
Drug: Saline

Registration Number: NCT01129583

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin	Botulinum Toxin Type A	100 U injected into biceps, 100 U into brachialis
Saline	Saline	100 U injected into biceps, 100 U into brachialis

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire	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

Name	Time	Method
Elbow Range of Motion	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.
Broberg Morrey Composite Elbow Function Score	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).