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

Sponsor
Restor3D
Study ID
NCT03289754
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • iPoly XE tibial insert with ConforMIS iTotal KRS — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 24, 2018
Status verified
Sep 2025
Primary completion
Jun 9, 2022
Completion
Jun 9, 2022

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: ConforMIS iTotal Knee with iPoly Insert
    The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts.

Primary Outcome Measure

Incidence of Device-related Complications [ Time Frame: 1 year ]

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