Functional Performance Evaluation of NU-FlexSIV Socket

Northwestern University

Status

Completed

Conditions

Artificial Limbs

Amputation

Treatments

Device: Northwestern University Flexible Sub-Ischial Vacuum Socket

Device: Ischial Containment Socket

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT02678247

W81XWH-15-1-0708

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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