Trial Outcomes & Findings for Botulinum Toxin as a Novel Treatment for Prevention of Post-Traumatic Elbow Stiffness (NCT NCT01129583)

Results Overview

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".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

1 year post-op

Results posted on

2015-03-27

Participant Flow

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.

Of the 59 patients assessed for eligibility, 41 patients were excluded based on the listed inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	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.	Saline Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
Overall Study STARTED	9	9
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Saline Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
Overall Study Death	1	0
Overall Study Lost to Follow-up	1	1
Overall Study Ipsilateral Upper Extremity Injury	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin n=9 Participants Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.	Saline n=9 Participants Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 13 • n=5 Participants	45 years STANDARD_DEVIATION 21 • n=7 Participants	49 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Botulinum Toxin n=9 Participants Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.	Saline n=9 Participants Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire	27 Scores on a Scale (0-100) Standard Error 11	54 Scores on a Scale (0-100) Standard Error 8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin n=9 Participants Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.	Saline n=9 Participants Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
Elbow Range of Motion	103 Degrees Standard Error 7.6	73 Degrees Standard Error 6.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Botulinum Toxin n=9 Participants Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.	Saline n=9 Participants Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
Broberg Morrey Composite Elbow Function Score	82 Score Standard Error 1.9	65 Score Standard Error 2.9

Adverse Events

Botulinum Toxin

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Botulinum Toxin n=9 participants at risk Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.	Saline n=9 participants at risk Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
Cardiac disorders Death	11.1% 1/9 • Number of events 1	0.00% 0/9

Other adverse events

Other adverse events
Measure	Botulinum Toxin n=9 participants at risk Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.	Saline n=9 participants at risk Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
Musculoskeletal and connective tissue disorders Unrelated Upper Extremity Injury	11.1% 1/9 • Number of events 1	11.1% 1/9 • Number of events 1

Additional Information

TTC research fellow

Columbia University Medical Center

Phone: 212-305-3912

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place