N/A
N=29
A Comparative Assessment of Transfemoral Prosthetic Sockets
Amputation · Amputation; Traumatic, Leg, Lower
Bottom Line
View on ClinicalTrials.gov: NCT04038580 ↗Enrolled (actual)
29
Serious AEs
3.1%
Results posted
Sep 2025
Primary outcome: Primary: Socket Fit Comfort Score — 7.0; 7.4; 7.9; 7.3 units on a scale — p=0.553
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laminated Socket (Device); Quatro (Device); Infinite Socket (Device); CJ Socket (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Socket Fit Comfort Score |
7.0; 7.4; 7.9; 7.3 | 0.553 |
| PRIMARY Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) |
54.6; 65.3; 61.7; 51.9; 85.1; 90.0 | 0.536 |
| PRIMARY Activities Specific Balance Confidence Scale |
68.7; 70.4; 67.8; 68.8 | 0.95 |
| PRIMARY Mobility as Measured by the 10-meter Walk Test |
1.06; 1.09; 1.07; 1.08 | .853 |
| PRIMARY Mobility as Measured by Timed Up and Go (TUG) |
15.0; 14.4; 14.4; 15.1 | 0.565 |
| PRIMARY Mobility as Measured by Five Times Sit To Stand (FTSTS) |
24.9; 21.8; 24.0; 23.9 | — |
| PRIMARY Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form |
50.5; 50.6; 52.0; 49.4 | .374 |
| SECONDARY Prosthetic Wear Time |
1.77; 1.49; 1.47; 1.05 | — |
| SECONDARY Time to Complete the L Test |
33.1; 32.2; 31.2; 32.6 | .574 |
| SECONDARY Steps Per Day Taken at Home |
2526; 2238; 2224; 2616 | — |
| SECONDARY Prosthetic Preference |
4; 33.4; 48.3; 37.4 | — |
Summary
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
Eligibility Criteria
Inclusion Criteria
- Unilateral lower-limb amputation
- Six months of independent ambulation
- Own and regularly wear a prosthesis with socket
- Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator"
Exclusion Criteria
- Pathology or injury of the intact limb
- Medication that affects their ability to walk
- Neurologic or cardiovascular disease
- Significant vision problems
- Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication
Data sourced from ClinicalTrials.gov (NCT04038580). 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.