N/A
Completed N=2
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
Traumatic Amputation of Arm
Source: ClinicalTrials.gov NCT01546675 ↗
Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Degrees of Shoulder Abduction Within the Prosthetic Socket — 27; 23.7; 42.5; 20.3 degrees
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degrees of Shoulder Abduction Within the Prosthetic Socket |
27; 23.7; 42.5; 20.3 | — |
| PRIMARY Degrees of Shoulder Internal Rotation Within the Prosthetic Socket |
17.1; 5.9; 14.1; 21.6 | — |
| PRIMARY Degrees of Shoulder Displacement Within the Prosthetic Socket |
4.4; 5.3; 3.1; 37.0 | — |
| SECONDARY Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) |
2.7; 3.2; 3.4; 5 | — |
| SECONDARY Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale |
3.4; 4.3; 5.4; 6.6 | — |
| SECONDARY Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale |
4.7; 5.5; 6.2; 4.7 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.
Exclusion Criteria
- Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
- Inability to tolerate wearing of a prosthetic socket
- Mental impairment that renders a subject unable to comply with the study
- Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
- Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
- Neuropathy, uncontrolled diabetes, receiving dialysis
- Any other significant comorbidity which would interfere with the study
- Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
- Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
- Women who are pregnant or who plan to become pregnant in the near future
Data sourced from ClinicalTrials.gov (NCT01546675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.