N/A
N=30
Functional Performance Evaluation of NU-FlexSIV Socket
Amputation · Artificial Limbs
Bottom Line
View on ClinicalTrials.gov: NCT02678247 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Socket Comfort Score (SCS) Between IC Socket and NU-FlexSIV Sockets at 7 Weeks. — 8.5; 6.8 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Northwestern University Flexible Sub-Ischial Vacuum Socket (Device); Ischial Containment Socket (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Socket Comfort Score (SCS) Between IC Socket and NU-FlexSIV Sockets at 7 Weeks. |
8.5; 6.8 | <0.001 sig |
| SECONDARY Walking Speed Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
1.14; 1.13 | 0.664 |
| SECONDARY Step Length Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
70.26; 68.56 | 0.026 sig |
| SECONDARY Hip Extension Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
-3.30; -3.10 | 0.847 |
| SECONDARY Hip Range of Motion Between the IC Socket and NU-FlexSIV Socket 7 Weeks. |
44.34; 43.30 | <0.017 sig |
| SECONDARY Trunk Motion Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
3.61; 3.73 | 0.7 |
| SECONDARY Orthotics and Prosthetics Users' Survey (OPUS) Lower-Extremity Functional Status Measure Between the IC Socket and NU-FlexSIV Socket at 7 Weeks |
58.3; 55.5 | 0.20 |
| SECONDARY Orthotics andProsthetics Users' Survey (OPUS) Health Related Quality of Life Index Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
69.1; 70.2 | 0.62 |
| SECONDARY Orthotics and Prosthetics Users' Survey (OPUS) Satisfaction With Device Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
35.1; 32.5 | 0.07 |
| SECONDARY 5-Times Rapid Sit-to-Stand Test (RSTS) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
12.7; 14.8 | 0.18 |
| SECONDARY Four-Square-Step Test (FSST) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
9.7; 9.5 | 0.47 |
| SECONDARY T-Test of Agility (T-Test) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
41.8; 41.4 | 0.68 |
Summary
The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.
Eligibility Criteria
Inclusion Criteria
- unilateral transfemoral amputation
- have used a prosthesis for two or more years
- have a residual limb that is stable in volume and free from wounds
- be physically fit enough to participate in the performance tests (Medicare Functional Classification Level K3 or K4)
- have no previous experience of the sub-ischial socket
- able to complete all visits for the duration of the protocol
Exclusion Criteria
- have a residual limb femur of less than 5-inches
- co-morbidities that affect function, including neurologic abnormalities (e.g. neuropathic pain that would interfere with the study)
- do not speak and read English
Data sourced from ClinicalTrials.gov (NCT02678247). 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.