Post Traumatic Stiffness
Conditions
Keywords
Botulinum Toxin, Elbow Stiffness
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.
Interventions
DRUGBotulinum Toxin Type A
Injection into the biceps brachii and brachialis immediately following the initial fracture surgery
DRUGSaline
Injection into the biceps brachii and brachialis immediately following the initial fracture surgery
Sponsors
Allergan
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the orthopaedic upper extremity trauma clinic of the primary investigator. The recruitment period was 49 months in length, from 11/2003 through 11/2007.
Pre-assignment details
Of the 59 patients assessed for eligibility, 41 patients were excluded based on the listed inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation. | 9 |
| Saline Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation. | 9 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Ipsilateral Upper Extremity Injury | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Saline | Botulinum Toxin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 21 | 52 years STANDARD_DEVIATION 13 | 49 years STANDARD_DEVIATION 17 |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 9 | 1 / 9 |
| serious Total, serious adverse events | 1 / 9 | 0 / 9 |
Outcome results
Primary
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
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.
Time frame: 1 year post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin | Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 27 Scores on a Scale (0-100) | Standard Error 11 |
| Saline | Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 54 Scores on a Scale (0-100) | Standard Error 8 |
p-value: 0.06t-test, 2 sided
Secondary
Broberg Morrey Composite Elbow Function Score
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).
Time frame: 6 months post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin | Broberg Morrey Composite Elbow Function Score | 82 Score | Standard Error 1.9 |
| Saline | Broberg Morrey Composite Elbow Function Score | 65 Score | Standard Error 2.9 |
p-value: 0.02t-test, 2 sided
Secondary
Elbow Range of Motion
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.
Time frame: 3 months post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin | Elbow Range of Motion | 103 Degrees | Standard Error 7.6 |
| Saline | Elbow Range of Motion | 73 Degrees | Standard Error 6.3 |
p-value: 0.01t-test, 2 sided