Trial Outcomes & Findings for Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM (NCT NCT01546675)

Results Overview

Shoulder abduction was performed to the subject's maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

After 4 weeks of home use (2 weeks for each socket style)

Results posted on

2014-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	Active Comparator: Traditional 1, Skeletal Stabilization 2 Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.	Experimental: Skeletal Stabilization 1, Traditional 2 Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator: Traditional 1, Skeletal Stabilization 2 n=1 Participants Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.	Experimental: Skeletal Stabilization 1, Traditional 2 n=1 Participants Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design	Total n=2 Participants Total of all reporting groups
Age, Continuous	20 years n=5 Participants	29 years n=7 Participants	24.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 4 weeks of home use (2 weeks for each socket style)

Population: One male and one female with traumatic amputation at the transhumeral level.

Shoulder abduction was performed to the subject's maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

Outcome measures

Outcome measures
Measure	Active Comparator: Traditional 1, Skeletal Stabilization 2 n=1 Participants Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.	Experimental: Skeletal Stabilization 1, Traditional 2 n=1 Participants Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
Degrees of Shoulder Abduction Within the Prosthetic Socket Skeletal Stabilization Socket	27 degrees	23.7 degrees
Degrees of Shoulder Abduction Within the Prosthetic Socket Traditional Socket	42.5 degrees	20.3 degrees

PRIMARY outcome

Timeframe: After 4 weeks of home use (2 weeks for each socket style)

Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

Outcome measures

Outcome measures
Measure	Active Comparator: Traditional 1, Skeletal Stabilization 2 n=1 Participants Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.	Experimental: Skeletal Stabilization 1, Traditional 2 n=1 Participants Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
Degrees of Shoulder Internal Rotation Within the Prosthetic Socket Skeletal Stabilization	17.1 degrees	5.9 degrees
Degrees of Shoulder Internal Rotation Within the Prosthetic Socket Traditional Socket	14.1 degrees	21.6 degrees

PRIMARY outcome

Timeframe: After 4 weeks of home use (2 weeks for each socket style)

A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

Outcome measures

Outcome measures
Measure	Active Comparator: Traditional 1, Skeletal Stabilization 2 n=1 Participants Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.	Experimental: Skeletal Stabilization 1, Traditional 2 n=1 Participants Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
Degrees of Shoulder Displacement Within the Prosthetic Socket Skeletal Stabilization Socket	4.4 degrees	5.3 degrees
Degrees of Shoulder Displacement Within the Prosthetic Socket Traditional Socket	3.1 degrees	37.0 degrees

SECONDARY outcome

Timeframe: After 4 weeks of home use (2 weeks for each socket style)

This 10 item scale includes items related to satisfaction with aspects of the prosthesis. It includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated on a 5 point scale from very dissatisfied to very satisfied. Scores are summed and the average of the 10 items are calculated. Higher scores indicate greater satisfaction. Scores range from 1-5.

Outcome measures

Outcome measures
Measure	Active Comparator: Traditional 1, Skeletal Stabilization 2 n=1 Participants Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.	Experimental: Skeletal Stabilization 1, Traditional 2 n=1 Participants Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) Skeletal Stabilization Socket	2.7 units on a scale	3.2 units on a scale
Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) Traditional Socket	3.4 units on a scale	5 units on a scale

SECONDARY outcome

Timeframe: after 2 weeks of home use of each socket type

The 8-item utility subscale includes items related to prosthetic socket utility including: comfort, fit, ease of donning and doffing and feel on the residual limb. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.

Outcome measures

Outcome measures
Measure	Active Comparator: Traditional 1, Skeletal Stabilization 2 n=1 Participants Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.	Experimental: Skeletal Stabilization 1, Traditional 2 n=1 Participants Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale Skeletal Stabilization Socket	3.4 units on a scale	4.3 units on a scale
Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale Traditional Socket	5.4 units on a scale	6.6 units on a scale

SECONDARY outcome

Timeframe: After 4 weeks of home use (2 weeks for each socket style)

The 6-item residual limb health scale includes items about the bothersome of sweating, smell, swelling, ingrown hairs, rashes and blisters. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.

Outcome measures

Outcome measures
Measure	Active Comparator: Traditional 1, Skeletal Stabilization 2 n=1 Participants Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.	Experimental: Skeletal Stabilization 1, Traditional 2 n=1 Participants Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale Skeletal Stabilization Socket	4.7 units on a scale	5.5 units on a scale
Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale Traditional Socket	6.2 units on a scale	4.7 units on a scale

Adverse Events

Cases

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

Linda Resnik, PT, PhD

Department of Veterans Affairs

Phone: 401-273-7100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place