Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System for
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Comprehensive Lower-limb Amputee Socket Survey (CLASS)
Study Overview
Brief Summary
The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.
Detailed Description
Design:
This clinical investigation will be of a single group non-randomized open label prospective repeated measures (ABBA) design comparing subject´s current conventional socket and the CONNECT TF. The subjects will be asked to use the CONNECT TF as their primary prosthesis for up to six weeks. Subject will be fitted with the same foot-pylon-knee prosthetic system as used with their current conventional socket, with the CONNECT TF socket.
Procedures:
There are four scheduled study events. At the initial visit, the first study event, for each subject a qualified researcher will obtain an informed consent. Prior to fitting the patient subject to CONNECT TF he/she will be asked to provide feedback and perform tasks on/using their current conventional prosthetic socket. The patient subjects will be fitted with the CONNECT TF within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain.
The CPO (Certified Prosthetis/Orthotist) will conduct the fitting and aligning of the CONNECT TF.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Lower limb amputees
- •Uni- or bilateral TF amputees
- •40 < body weight < 125Kg
- •Activity level: K1-K2;
- •Liner size: 28-45;
- •Max 1 user in sizes 28 and 45, respectively
- •Residual limb parameters; perineum to distal end: 205 to 280 mm
- •Older than 18 years
- •Prosthetic users for more than 3 months
- •Components of conventional socket functionally compatible to Össur components (foot-pylon-knee combination)
- •Users understanding the function of the device
- •Willing and able to participate in the study and follow the protocol
Exclusion Criteria
- •Other amputees
- •40> body weight > 125Kg
- •Amputees with broken skin on the residual limb
- •Younger than 18 years
- •Prosthetic users for less than 3 months
- •Using no liner
- •Using a microprocessor controlled prosthetic knee not manufactured by Össur
- •Users not understanding the function of the device
Arms & Interventions
CONNECT TF
Trans-femoral amputees currently using a conventional handmade socket will be fitted with the CONNECT TF adaptable socket system for 6 weeks and their current existing conventional socket for 6 weeks, data collection on both sockets will be performed and outcomes compared.
Intervention: CONNECT TF adaptable socket system (Device)
CONNECT TF
Trans-femoral amputees currently using a conventional handmade socket will be fitted with the CONNECT TF adaptable socket system for 6 weeks and their current existing conventional socket for 6 weeks, data collection on both sockets will be performed and outcomes compared.
Intervention: Any conventional handmade socket (Device)
Outcomes
Primary Outcomes
Comprehensive Lower-limb Amputee Socket Survey (CLASS)
Time Frame: 6 weeks
CLASS is a self-report measure of prosthetic socket satisfaction for lower limb amputees, designed to provide an effective means of communication for the patient to describe with clarity, the quality of their socket fit during common activities. CLASS evaluates static and dynamic features of socket stability, suspension, comfort and appearance and has been reported to be a reliable, quick and easy report measure.
Secondary Outcomes
- Balance during ambulation (TUG)(6 weeks)
- Prosthesis evaluation questionnaire - Sounds (PEQ-Sounds)(6 weeks)
- Prosthesis evaluation questionnaire - Residual limb health (PEQ- RLH)(6 weeks)
- Mobility (2MWT)(6 weeks)