Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System

NCT04388488 | Completed FDA Device

• 1 other identifier: CIP2020021338
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Prosthesis User; Amputation

Outcome Measures

Primary Outcomes (1)

• Comprehensive Lower-limb Amputee Socket Survey (CLASS)

  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.

  6 weeks

Secondary Outcomes (4)

• Prosthesis evaluation questionnaire - Residual limb health (PEQ- RLH)

  6 weeks

• Prosthesis evaluation questionnaire - Sounds (PEQ-Sounds)

  6 weeks

• Mobility (2MWT)

  6 weeks

• Balance during ambulation (TUG)

  6 weeks

Study Arms (1)

CONNECT TF

EXPERIMENTAL

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.

Device: CONNECT TF adaptable socket system; Device: Any conventional handmade socket

Interventions

CONNECT TF adaptable socket system DEVICE

Prefabricated, adaptable socket system

CONNECT TF

Any conventional handmade socket DEVICE

Subjects current socket

CONNECT TF

Eligibility Criteria

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

You may qualify if:

• Lower limb amputees
• Uni- or bilateral TF amputees
• \< 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

You may not qualify if:

• Other amputees
• \> 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

Sponsors & Collaborators

• Össur Iceland ehf: lead
• Indiana University: collaborator

Study Sites (2)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

IU Health Comprehensive Wound Center at Methodist Hospital

Indianapolis, Indiana, 46206-1367, United States

Location

Study Officials

• Sashwati Roy, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This clinical investigation will be of a single group non-randomized open label prospective repeated measures (ABBA) design.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 14, 2020
• Study Start: August 3, 2020
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)