NCT02678247

Functional Performance Evaluation of NU-FlexSIV Socket

Functional Performance Evaluation of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket for Persons With Transfemoral Amputation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed clinical trial will be an assessor-blinded prospective randomized cross-over trial wherein participants with unilateral transfemoral amputation will be randomized to using one of two socket conditions (i.e., sub-ischial or ischial containment) before crossing over to the other socket condition. Random allocation (computer-generated) utilizing blocks of random size will be used to assign the initial treatment condition. The trial will be balanced such that all subjects will receive all treatments (i.e., both socket conditions) and that all subjects will participate for the same number of periods (i.e., two). While a washout period is not strictly necessary, it is effectively included as subjects will need to transition back to their usual, pre-study socket/prosthesis while the second test socket is fabricated. Allocation of intervention will be concealed from the investigators until after a subject is enrolled. The starting socket design will be enclosed in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened sequentially and only after the participant's name and other details are written on the appropriate envelope. Blinding of prosthetic interventions is challenging given that they are devices that must be custom-fabricated and donned each day by the subject. Hence, for this study only the assessor will be blinded. The blinded assessor will be responsible for administration of the clinical performance and patient-reported measures as well as processing of motion analysis data.

Conditions

• Amputation
• Artificial Limbs

Interventions

Type	Name	Description
DEVICE	Northwestern University Flexible Sub-Ischial Vacuum Socket	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.
DEVICE	Ischial Containment Socket	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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-02-09
• Last updated: 2021-06-15
• Results posted: 2021-04-27

Locations

3 sites across 1 country: United States