An Investigation Into a New Manufacture Technique of Trans-femoral Sockets
Public ClinicalTrials.gov record NCT04312724. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MSS - Clinical Investigation An Investigation of a New Manufacture Technique of a Trans-femoral Socket and Its Function for Amputees.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The investigation will be of a single group prospective pre/post design with follow up at 6 weeks (6WFU) and 6 months (6MFU); comparing to outcomes at baseline (BL). Device(s) being tested: Interchangeably: Direct Socket TF; DS-TF; DS Trans-femoral. The DS-TF is a trans-femoral (TF) set-up of the currently marketed trans-tibial version. It is not marketed in the USA and has not been registered with the FDA. The comparator is the current socket the subject is using when enrolled in the study. Subjects recruited: Minimum 50 Inclusion criteria: 50Kg\< body weight \< 160Kg Cognitive ability to understand all instructions and questionnaires in the study; Patients who have undergone a transfemoral amputation \> 1 year post amputation Older than 18 years Willing and able to participate in the study and follow the protocol Circular dimension of 40-65 cm at the crotch Residual limb length at least 20 cm from ischium to distal end Currently using a prosthetic liner Locking users that can successfully be fitted with Iceross® Transfemoral Locking, OR Seal-In users that can successfully be fitted with either Iceross Seal-In® X5 TF or Iceross Transfemoral Seal-In® Exclusion criteria: 50Kg\> body weight \> 160Kg Users with cognitive impairment Patients who have undergone a transfemoral amputation \<1 year post amputation Younger than 18 years Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons Circular dimension of less than 40 cm or greater than 65 cm at the crotch Residual limb length less than 20 cm from ischium to distal end Currently not using a prosthetic liner
Study identification
- NCT ID
- NCT04312724
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 47 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 29, 2018
- Primary completion
- Jun 14, 2020
- Completion
- Jun 30, 2020
- Last update posted
- Nov 19, 2020
2018 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 8
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Artificial Limb Specialists | Mobile | Alabama | 36606 | — |
| Alabama Artificial Limb Specialists | Montgomery | Alabama | 36116 | — |
| Alabama Artificial Limb Specialists | Opelika | Alabama | 36801 | — |
| Van Der Watt Prosthetics & Orthotics | Greenwood | Arkansas | 72936 | — |
| Tillges Certified Orthotic Prosthetic Inc | Maplewood | Minnesota | 55109 | — |
| Sampson's Prosthetics Lab | Albany | New York | 12206 | — |
| Sampson's Prosthetics Lab | Schenectady | New York | 12304 | — |
| Eastside Orthotics and Prosthetics | Portland | Oregon | 97230 | — |
| Union Orthotics & Prosthetics Co | Cranberry Township | Pennsylvania | 16066 | — |
| Union Orthotics & Prosthetics Co | East Rochester | Pennsylvania | 15074 | — |
| Union Orthotics & Prosthetics Co | Greensburg | Pennsylvania | 15601 | — |
| Union Orthotics & Prosthetics Co | Pittsburgh | Pennsylvania | 15201 | — |
| Union Orthotics & Prosthetics Co | Pittsburgh | Pennsylvania | 15236 | — |
| Victory Orthotics and Prosthetics Inc. | Johnson City | Tennessee | 37604 | — |
| Victory Orthotics and Prosthetics Inc. | Kingsport | Tennessee | 37660 | — |
| Victory Orthotics and Prosthetics Inc. | Knoxville | Tennessee | 37922 | — |
| Virginia Prosthetics and Orthotics | Roanoke | Virginia | 24012 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04312724, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 19, 2020 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04312724 live on ClinicalTrials.gov.