NCT03289754

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

A Prospective Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System and iPoly XE Tibial Inserts

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is prospective and single-center. Subjects will be implanted with an iTotal® CR Knee Replacement System in conjunction with an iPoly XE insert. The study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will be located in Germany. The study subjects will be followed for 10 years post implant.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-24
• Primary completion: 2022-06-09
• Completion: 2022-06-09
• First posted: 2017-09-21
• Last updated: 2025-10-16
• Results posted: 2025-10-16

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study