An interventional study of Skeletal Stabilization in Traumatic Amputation of Arm, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-24.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.
In the past decade, advances in upper limb socket design and technology have been proposed to increase comfort and decrease perceived weight of the prosthesis. There have been no scientific studies to date that have evaluated the benefits of these designs, and thus no evidence to support use of one type of prosthetic socket design over another. Thus, the overall purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization.
101 studies on the registry are indexed under Amputation, Traumatic; 14 are open to participants now.
This study's enrollment of 2 is below the median of 13 across 68 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.
Other: Skeletal Stabilization
Subjects using the socket hypothesized to increase skeletal stabilization and Traditional Socket and in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.
Other: Skeletal Stabilization
Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization
Also known as: Skeletal Stabilization Socket
Degrees of Shoulder Abduction Within the Prosthetic Socket
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)
Time frame: After 4 weeks of home use (2 weeks for each socket style)
Degrees of Shoulder Internal Rotation Within the Prosthetic Socket
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)
Time frame: After 4 weeks of home use (2 weeks for each socket style)
Degrees of Shoulder Displacement Within the Prosthetic Socket
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)
Time frame: After 4 weeks of home use (2 weeks for each socket style)
Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)
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.
Time frame: After 4 weeks of home use (2 weeks for each socket style)
Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale
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.
Time frame: after 2 weeks of home use of each socket type
Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale
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.
Time frame: After 4 weeks of home use (2 weeks for each socket style)
| Milestone | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
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)
| degrees | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 |
|---|---|---|
| Skeletal Stabilization Socket | 27 | 23.7 |
| Traditional Socket | 42.5 | 20.3 |
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.
| units on a scale | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 |
|---|---|---|
| Skeletal Stabilization Socket | 2.7 | 3.2 |
| Traditional Socket | 3.4 | 5 |
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.
| units on a scale | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 |
|---|---|---|
| Skeletal Stabilization Socket | 3.4 | 4.3 |
| Traditional Socket | 5.4 | 6.6 |
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)
| degrees | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 |
|---|---|---|
| Skeletal Stabilization | 17.1 | 5.9 |
| Traditional Socket | 14.1 | 21.6 |
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)
| degrees | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 |
|---|---|---|
| Skeletal Stabilization Socket | 4.4 | 5.3 |
| Traditional Socket | 3.1 | 37.0 |
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.
| units on a scale | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 |
|---|---|---|
| Skeletal Stabilization Socket | 4.7 | 5.5 |
| Traditional Socket | 6.2 | 4.7 |
Collected over Adverse Event Data were collected during each participants study duration.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cases | — | 0/2 (0%) | 0/2 (0%) |
Cross-over design. Each subject participated under each condition. Total of 2 subjects.
| Age, Continuous(years) | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 | Total |
|---|---|---|---|
| Mean | 20 (20 to 20) | 29 (29 to 29) | 24.5 (20 to 29) |
| Sex: Female, Male(Participants) | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Active Comparator: Traditional 1, Skeletal Stabilization 2 | Experimental: Skeletal Stabilization 1, Traditional 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
US Department of Veterans Affairs