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Prosthetics

Prosthetic Socket Design for Amputees

N/A
Recruiting
Led By William Anderst, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Transfemoral prosthesis user
18-80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 seconds
Awards & highlights

Study Summary

This trial will study the effects of different types of prosthetic sockets on trans-femoral amputees in a randomized way. The findings of this trial will be used in a clinical setting to help fit trans-femoral amputees with prosthetic sockets.

Who is the study for?
This trial is for individuals aged 18-80 who use a transfemoral prosthesis, can walk unassisted on a treadmill, and weigh less than 125 kg. It's not suitable for those with high radiation exposure, pregnant women, or anyone clinically diagnosed with osteoporosis.Check my eligibility
What is being tested?
The study is testing specific standardized changes to the design of transfemoral prosthetic sockets. Participants will experience different socket modifications in a randomized order to prepare for future trials on individual fitting methods.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions related to prosthetic socket fittings, significant side effects are not anticipated. However, participants may experience discomfort or skin irritation at the site where the prosthesis connects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use a prosthetic leg that attaches at the thigh.
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I am between 18 and 80 years old.
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I can walk by myself on a treadmill.
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I use a prosthetic leg that attaches at the thigh.
Select...
I am between 18 and 80 years old.
Select...
I can walk by myself on a treadmill.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 seconds
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 seconds for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Residual Femur motion
Skin strain
Socket pressure
Secondary outcome measures
Gait symmetry
Hip Range of Motion
Hip flexion/extension
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Unmodified Socket + 8 Socket Modifications in Random OrderExperimental Treatment1 Intervention
The sequence of the 9 different interventions (original socket and 8 versions derived from it) is randomized for each participant. The number of participants is smaller than the number of possible permutations. Therefore the enacted ordering is randomly selected from the pool of possible orderings. Participants walk for less than 10 minutes with every socket type while data is being collected.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,906 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,569 Total Patients Enrolled
William Anderst, PhDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
126 Total Patients Enrolled

Media Library

Trans-femoral prosthetic socket (Prosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT05041998 — N/A
Prosthetics Research Study Groups: Unmodified Socket + 8 Socket Modifications in Random Order
Prosthetics Clinical Trial 2023: Trans-femoral prosthetic socket Highlights & Side Effects. Trial Name: NCT05041998 — N/A
Trans-femoral prosthetic socket (Prosthetics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041998 — N/A

Frequently Asked Questions

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

Are senior citizens being included in this experiment?

"Per the specific inclusion criteria for this clinical trial, participants must fall between 18 and 80 years of age."

Answered by AI

To what demographic is this clinical experiment open?

"Enrollees in this study must satisfy the following qualifications: 18-80 years of age, possess a transfemoral prosthetic device, have a body weight under 125 kg, and be able to ambulate unaided on an exercise treadmill. There are thirty positions available for individuals with artificial limbs."

Answered by AI

What are the research objectives of this clinical trial?

"This study will assess Socket pressure as its primary outcome, and measure secondary outcomes such as Hip Range of Motion (manually measured with a goniometer), Gait Symmetry (measured by way of peak trunk lean and average hip flexion/extension via motion capture system) and Static Displacement (distance from the most distal point on the residual femur to socket interior under weightbearing)."

Answered by AI

Are there any opportunities to become involved in the trial at this time?

"The trial is actively searching for enrolment, and the information on clinicaltrials.gov affirms this fact. It first appeared online in September 2021 before being revised most recently as of September 2022."

Answered by AI

How many individuals are currently being administered treatment through this clinical trial?

"Affirmative. According to the clinicaltrials.gov platform, this medical research is currently recruiting participants. Inception of the trial was on September 1st 2021 and it has been modified recently as of September 6th 2022. 30 individuals must be enrolled from two separate sites."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
University of Pittsburgh
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Pittsburgh: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
TrialsJournal
Within-subject Effects of Standardized Prosthetic Socket Modifications on Physical Function and Patient-reported Outcomes
Anderst, William, Goeran Fiedler, Kentaro Onishi, Gina McKernan, Tom Gale, and Paige Paulus. 2022. “Within-subject Effects of Standardized Prosthetic Socket Modifications on Physical Function and Patient-reported Outcomes”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06205-z.
clinicaltrials.govStudy
Quantitatively-informed Socket Design Process
William Anderst 2021. "Quantitatively-informed Socket Design Process". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05041998.
~1 spots leftby Jun 2024
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