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Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

NCT05190354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-08-24

No results posted yet for this study

Summary

Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.

Conditions

  • Amputation
  • Prosthesis User

Interventions

DEVICE

Xtremity Polymer Prosthetic Socket

Subjects with transtibial unilateral or bilateral amputation who have experience using a standard carbon fiber or high temperature thermoplastic prosthetic socket will be evaluated and fitted with a below knee prosthesis socket

Sponsors & Collaborators

  • Medical Creations, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Berke, MS, CP, FAAOP · Medical Creations

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2022-05-11
Completion
2022-06-24
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT05190354 on ClinicalTrials.gov