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A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts

NCT03289754 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-10-16

Study results available
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Summary

This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted.

Conditions

Interventions

DEVICE

iPoly XE tibial insert with ConforMIS iTotal KRS

The implants are constructed to conform to the surface of the patient's femoral condyle and proximal tibia, replacing the damaged cartilage with a smooth articulating surface. The femoral component and tibial tray are manufactured from cobalt chromium molybdenum alloy. The tibial insert and patellar component are manufactured from ultra-high molecular weight polyethylene.

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Principal Investigators

  • Philipp Drees · University- Mainz

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2022-06-09
Completion
2022-06-09
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03289754 on ClinicalTrials.gov