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OrthoPure™ XT Pilot Clinical Study

NCT03562299 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-11-21

No results posted yet for this study

Summary

To evaluate the clinical safety and obtain preliminary effectiveness data for OrthoPure™ XT device in a small group of US patients at 12 and 24 months. The clinical experience obtained from this study will be used to develop a pivotal study for follow up in a larger patient population.

Conditions

  • Knee Injuries
  • Anterior Cruciate Ligament (ACL) Reconstruction

Interventions

DEVICE

OrthoPure™ XT

A decellularized, sterile, single use, xenograft device for reconstruction of the anterior cruciate ligament

Sponsors & Collaborators

  • TRX Orthopedics

    lead INDUSTRY

Principal Investigators

  • Tom Carter · St. Joseph's Outpatient Surgery Center

  • Jack Farr · OrthoIndy Hospital South

  • David Caborn · Jewish Hospital and St. Mary's Healthcare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

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 NCT03562299 on ClinicalTrials.gov