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Quantitatively-informed Socket Design Process

NCT05041998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-08-14

No results posted yet for this study

Summary

This study will investigate the effects of specific standardized modifications to trans-femoral prosthetic sockets in a randomized within-subject design. This is in preparation for a subsequently planned clinical trial to validate the findings by implementing them into a fitting method for individual sockets.

Conditions

  • Artificial Limbs

Interventions

DEVICE

Trans-femoral prosthetic socket

Unmodified) A custom-made check socket serving as the interface between residual limb and prosthesis 1. Soft socket (Socket made from softer material than unmodified original) 2. Stiff socket (Socket made from stiffer material than unmodified original) 3. moderately lower brim height (Brim of the socket is lowered by 10% of socket length compared to unmodified original) 4. slightly lower brim height (Brim of the socket is lowered by 5% of socket length compared to unmodified original) 5. Oversized socket (The socket volume is 6% larger than the unmodified original) 6. Undersized socket (The socket volume is 6% smaller than the unmodified original) 7. CAT-CAM influenced geometry (The cross sectional geometry of the socket is modelled following the contoured adducted trochanteric-controlled alignment method (CAT-CAM)) 8. MAS influenced geometry (The cross sectional geometry of the socket is modelled following the Marlo Anatomic Socket (MAS) template)

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • William Anderst, PhD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-03-01
Completion
2025-08-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05041998 on ClinicalTrials.gov