Trial Outcomes & Findings for Comparing Outcomes of Elbow Extension Tendon Transfers (NCT NCT01204736)

Results Overview

Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate. We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions. Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds. The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

At least one year post surgery

Results posted on

2016-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Subjects with posterior deltoid-to-triceps tendon transfers	Group 2 Subjects with biceps-to-triceps tendon transfers	Group 3 Subjects with cervical SCI who have not had tendon transfers	Group 4 Unimpaired control subjects
Overall Study STARTED	4	5	3	2
Overall Study COMPLETED	4	5	3	2
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Outcomes of Elbow Extension Tendon Transfers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=4 Participants Subjects with posterior deltoid-to-triceps tendon transfers	Group 2 n=5 Participants Subjects with biceps-to-triceps tendon transfers	Group 3 n=3 Participants Subjects with cervical SCI who have not had tendon transfers	Group 4 n=2 Participants Unimpaired control subjects	Total n=14 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 7.3 • n=5 Participants	26.6 years STANDARD_DEVIATION 8.2 • n=7 Participants	45.2 years STANDARD_DEVIATION 11.5 • n=5 Participants	33.5 years STANDARD_DEVIATION 0.7 • n=4 Participants	37.3 years STANDARD_DEVIATION 12.1 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants

PRIMARY outcome

Timeframe: At least one year post surgery

Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate. We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions. Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds. The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.

Outcome measures

Outcome measures
Measure	Group 1 n=6 Upper limbs Subjects with posterior deltoid-to-triceps tendon transfers	Group 2 n=7 Upper limbs Subjects with biceps-to-triceps tendon transfers	Group 3 n=3 Upper limbs Subjects with cervical SCI who have not had tendon transfers	Group 4 n=2 Upper limbs Unimpaired control subjects
Elbow Extension Strength	2.74 Newton-Meters Standard Deviation 0.22	8.8 Newton-Meters Standard Deviation 3.9	0 Newton-Meters Standard Deviation 0	68.7 Newton-Meters Standard Deviation 12.3

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wendy Murray

Rehabilitation Institute of Chicago

Phone: 3122386965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place