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

NCT05040165 | Completed FDA Device

• 1 other identifier: CIP2019052102
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.

Conditions

Prosthesis Failure

Outcome Measures

Primary Outcomes (2)

• Cumulative failure rate

  TPE material durability

  3 months

• Cumulative failure rate

  TPE material durability

  6 months

Study Arms (1)

Failure time analysis

EXPERIMENTAL

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.

Device: Iceform liner and sleeve

Interventions

Iceform liner and sleeve DEVICE

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.

Failure time analysis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Össur Iceland ehf: lead

Study Sites (1)

ProofPilot

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin L Pratt, CP

  Össur

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: September 10, 2021
• Study Start: December 8, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)