Functional Performance Evaluation of NU-FlexSIV Socket

NCT02678247 | Completed Results

• 1 other identifier: W81XWH-15-1-0708
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Amputation; Artificial Limbs

Keywords

prosthesis; prosthetic socket; transfemoral amputation; socket comfort; gait biomechanics

Outcome Measures

Primary Outcomes (1)

• Socket Comfort Score (SCS) Between IC Socket and NU-FlexSIV Sockets at 7 Weeks.

  Socket comfort was assessed after each socket was worn for 7 weeks. SCS is an ordinal scale where the subject responds to the question, "On a 0 to 10 scale, if 0 represents the most uncomfortable socket fit you can imagine, and 10 represents the most comfortable socket fit, how would you score the comfort of the socket of your artificial limb at the moment?"

  7 weeks

Secondary Outcomes (11)

• Walking Speed Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.

  7 weeks

• Step Length Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.

  7 weeks

• Hip Extension Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.

  7 weeks

• Hip Range of Motion Between the IC Socket and NU-FlexSIV Socket 7 Weeks.

  7 weeks

• Trunk Motion Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.

  7 weeks

Study Arms (2)

NU-FlexSIV Socket

ACTIVE COMPARATOR

The Northwestern University Flexible Sub-Ischial Vacuum Socket is a novel socket design for transfemoral amputees.

Device: Northwestern University Flexible Sub-Ischial Vacuum Socket; Device: Ischial Containment Socket

IC Socket

ACTIVE COMPARATOR

The Ischial Containment Socket is the standard of care socket design for transfemoral amputees.

Device: Northwestern University Flexible Sub-Ischial Vacuum Socket; Device: Ischial Containment Socket

Interventions

Northwestern University Flexible Sub-Ischial Vacuum Socket DEVICE

NU-FlexSIV sockets have lower proximal trim lines, do not impinge on the pelvis, are highly flexible so as to allow better comfort during sitting and when muscles move within the socket during activity, and are held securely to the residual limb by suction from a vacuum pump and from compression exerted by the deliberately undersized liner and socket.

Also known as: NU-FlexSIV Socket

IC Socket; NU-FlexSIV Socket

Ischial Containment Socket DEVICE

Ischial Containment (IC) sockets are more rigid and have a narrower medio-lateral dimension than anterior-posterior dimension. The socket encapsulates the ischium, ischial ramus and greater trochanter, limiting hip range of motion and comfort.

Also known as: IC Socket

IC Socket; NU-FlexSIV Socket

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• United States Department of Defense: collaborator
• Jesse Brown VA Medical Center: collaborator
• Scheck and Siress: collaborator

Study Sites (3)

Jesse Brown VA Medical Center Motion Analysis Research Laboratory

Chicago, Illinois, 60611, United States

Location

Northwestern University Prosthetics-Orthotics Center

Chicago, Illinois, 60611, United States

Location

Scheck and Siress Prosthetics Orthotics

Oakbrook Terrace, Illinois, 60181, United States

Location

Related Publications (2)

• Fatone S, Stine R, Caldwell R, Angelico J, Gard SA, Oros M, Major MJ. Comparison of Ischial Containment and Subischial Sockets Effect on Gait Biomechanics in People With Transfemoral Amputation: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1515-1523. doi: 10.1016/j.apmr.2022.02.013. Epub 2022 Mar 13.

  PMID: 35296398 DERIVED

• Fatone S, Caldwell R, Angelico J, Stine R, Kim KY, Gard S, Oros M. Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2021 Nov;102(11):2063-2073.e2. doi: 10.1016/j.apmr.2021.05.016. Epub 2021 Jun 29.

  PMID: 34214499 DERIVED

Results Point of Contact

• Title: Dr. Stefania Fatone, Principle Investigator
• Organization: Northwestern University

s-fatone@northwestern.edu

3125035717

Study Officials

• Stefania Fatone, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 9, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 15, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Once results are published.
• Access Criteria: Upon request, the PI will share de-identified data and outcomes. If the requests are excessive, data will be made available via a link on the Northwestern University Prosthetics-Orthotics Center (NUPOC) website.

Locations

US (3)