search
Back to results

Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner

Primary Purpose

Prosthesis Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iceform liner and sleeve
Sponsored by
Össur Ehf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prosthesis Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Trans-tibial amputee
  • Uses an Iceform or Willow Wood Alpha Classic (Uniform profile) liner
  • Willing and able to participate in the study and follow the protocol
  • Confident prosthetic users for more than 3 months
  • Older than 18 years

Exclusion Criteria:

  • Participating in another research study
  • Participants of another research study during previous 2 months.

Sites / Locations

  • ProofPilot

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Failure time analysis

Arm Description

The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc. Secondary objectives relate to gather information on how amputees use the liner, specifically: Intensity of use (days/week and hours/day) Alternation; i.e. switching every other day between liners Use of personal hygiene or cosmetic products The following performance and safety aspects are to be verified: • The ICEFORM line of devices are durable over their intended use lifetime.

Outcomes

Primary Outcome Measures

Cumulative failure rate
TPE material durability
Cumulative failure rate
TPE material durability

Secondary Outcome Measures

Full Information

First Posted
November 18, 2020
Last Updated
September 9, 2021
Sponsor
Össur Ehf
search

1. Study Identification

Unique Protocol Identification Number
NCT05040165
Brief Title
Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner
Official Title
Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 8, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Össur Ehf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.
Detailed Description
Potential subjects will be identified from the customer base of a relevant clinic. If a potential participant may fit the inclusion and exclusion criteria, he/she will be contacted by a Co-Investigator (CI) via telephone. During the telephone call the CI will verify if they are interested in participating in a study and will initiate the enrollment procedure. If interest is expressed at this point they will answer some screening questions and if the eligibility criteria is met the subject is offered to enroll by getting a study invite through ProofPilot, the EDS, and an appointment to come in for initial fitting will be set up. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered at this time. Following this the subject will log into ProofPilot online and go through the e-ICF, if signed, the subject will answer a profile questionnaire. The next step will be an appointment, subject comes into their clinic and gets the investigational device. In some cases, the subject will get the liner shipped to their home address. This will only be done upon subjects request due to long distance from clinic. And only for very confident prosthetic users which are used to handle a new liner by themselves. Potential risk of participating in the investigation will be explained to the subject at this point. The CIs will communicate to the study monitors the number of users that have been identified that meet the inclusion/exclusion criteria and are willing to participate. During the clinical visit the subjects will only be fitted to the Iceform investigational liner. Profile and relevant contact information will already have been collected via the EDS. Subjects will then receive a prompt monthly, either via email, SMS or smartphone notification, to fill in the EDS questionnaire, and perform any tasks as applicable. If a subject reports a failure he/she will be instructed to stop using the liner, the remaining gift cards will be delivered and their participation ends. Otherwise, participation will end at 6 months. The subject gets to keep the investigational device at the end of the study, therefore there is no need for an additional visit. Subjects that report a failure of the TPE material may be contacted by the Coordinating Investigator or CI if the root cause of the failure cannot be confidently determined from the data collected with the EDS system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Failure time analysis
Arm Type
Experimental
Arm Description
The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc. Secondary objectives relate to gather information on how amputees use the liner, specifically: Intensity of use (days/week and hours/day) Alternation; i.e. switching every other day between liners Use of personal hygiene or cosmetic products The following performance and safety aspects are to be verified: • The ICEFORM line of devices are durable over their intended use lifetime.
Intervention Type
Device
Intervention Name(s)
Iceform liner and sleeve
Intervention Description
Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.
Primary Outcome Measure Information:
Title
Cumulative failure rate
Description
TPE material durability
Time Frame
3 months
Title
Cumulative failure rate
Description
TPE material durability
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trans-tibial amputee Uses an Iceform or Willow Wood Alpha Classic (Uniform profile) liner Willing and able to participate in the study and follow the protocol Confident prosthetic users for more than 3 months Older than 18 years Exclusion Criteria: Participating in another research study Participants of another research study during previous 2 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin L Pratt, CP
Organizational Affiliation
Össur
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProofPilot
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner

We'll reach out to this number within 24 hrs