Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner
Prosthesis Failure
About this trial
This is an interventional supportive care trial for Prosthesis Failure
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.
Sites / Locations
- ProofPilot
Arms of the Study
Arm 1
Experimental
Failure time analysis
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.