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Prosthetic Suspension System

Ventilating vs Non-Ventilating Suspension Systems for Amputation

N/A
Recruiting
Research Sponsored by Össur Ehf
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will compare the effects of a ventilating vs. non-ventilating suspension system on skin health for those with transfemoral amputation.

Who is the study for?
This trial is for individuals over 18 years old who have had a below-knee amputation and weigh between 50-136 kg. They should be able to understand instructions, use a prosthetic liner, and have been confident prosthetic users for more than three months. The study excludes those not fitting these criteria or unable to follow the protocol.Check my eligibility
What is being tested?
The investigation compares two types of lower limb prosthetic suspension systems: one with ventilation (AeroFit Seal-In Liner/Socket) and one without (Seal-In Silicone Liner). It aims to assess user-reported benefits on skin health from using these systems in daily life.See study design
What are the potential side effects?
While specific side effects are not listed, potential issues may include discomfort, skin irritation or damage due to the fit and function of the liners and sockets being tested.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Subject perceived skin health (PEQ-RLH)
Secondary outcome measures
Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.
Subject perceived activity restriction and prosthesis use, TAPES-R
Subject perceived quality of life EQ-5D-5L

Trial Design

2Treatment groups
Experimental Treatment
Group I: Crossover BABExperimental Treatment2 Interventions
Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times.
Group II: Crossover ABAExperimental Treatment2 Interventions
Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times.

Find a Location

Who is running the clinical trial?

Össur EhfLead Sponsor
20 Previous Clinical Trials
3,807 Total Patients Enrolled

Media Library

AeroFit Seal-In Liner / Socket (Prosthetic Suspension System) Clinical Trial Eligibility Overview. Trial Name: NCT05925712 — N/A
Skin Health Research Study Groups: Crossover ABA, Crossover BAB
Skin Health Clinical Trial 2023: AeroFit Seal-In Liner / Socket Highlights & Side Effects. Trial Name: NCT05925712 — N/A
AeroFit Seal-In Liner / Socket (Prosthetic Suspension System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05925712 — N/A
Skin Health Patient Testimony for trial: Trial Name: NCT05925712 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this research endeavor still open?

"Affirmative, according to clinicaltrials.gov the current recruitment status of this trial is open. This medical study was initially posted on June 6th 2023 and revised most recently on June 27th 2023. The research necessitates 60 participants from 5 different locations."

Answered by AI

In what areas is this clinical experiment being conducted?

"The current clinical trial has sites in Indianapolis, Bay City and Perrysburg as well as 5 other cities. To minimize travel demands, patients should pick the closest facility to them if they decide to take part."

Answered by AI

How many participants are being admitted to this clinical test?

"The trial's sponsor, Össur Ehf, requires a total of 60 eligible patients to proceed. Two such medical sites are SRT Prosthetics & Orthotics NPC in Indianapolis and Oakland Orthopedic in Bay City, Michigan."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
SRT Prosthetics & Orthotics NPC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Intrigued. Would love to find a prosthetic system to help aid in weight loss. Over abundance of sweat on residential limb causes frustration. Past-time favorite activity is rollerblading.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When does the trial start?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Aerofit Post Market Investigation
2023. "Aerofit Post Market Investigation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05925712.
~5 spots leftby May 2024
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