NCT03289754

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

Terminated NA Results posted Last updated 16 October 2025

What this trial tests

NA trial testing iPoly XE tibial insert with ConforMIS iTotal KRS in Knee Osteoarthritis in 52 participants. Terminated before completion.

Timeline

24 January 2018

Primary endpoint
9 June 2022

9 June 2022

Quick facts

Lead sponsor	Restor3D
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	52
Start date	24 January 2018
Primary completion	9 June 2022
Estimated completion	9 June 2022
Sites	1 location across Germany

Drugs / interventions tested

• iPoly XE tibial insert with ConforMIS iTotal KRS

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Restor3D

Who can join

18 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Device-related Complications Primary · 1 year

Adverse events were categorized as "Device Probably Related", "Device Possibly Related", Device All Related", or "Device Not Related" by the care team for all adverse events (as per the definitions of adverse events on clinicaltrials.gov). Outcome metrics are given in the form of "Events per Patient" which was calculated by dividing the number of adverse in each category by the number of baseline patients.

Group	Value	95% CI
"Device Probably Related" Adverse Event	0.02
"Device Possibly Related" Adverse Event	0.31
"Device All Related" Adverse Event	0.33
"Device Not Related" Adverse Event	0.39

Incidence of Procedure-Related Complications Primary · 1 year

Adverse events were categorized as "Procedure Probably Related", "Procedure Possibly Related", Procedure All Related", or "Procedure Not Related" by the care team for all adverse events (as per the definitions of adverse events on clinicaltrials.gov). Outcome metrics are given in the form of "Events per Patient" which was calculated by dividing the number of adverse in each category by the number of baseline patients.

Group	Value	95% CI
"Procedure Probably Related" Adverse Event	0.1
"Procedure Possibly Related" Adverse Event	0.14
"Procedure All Related" Adverse Event	0.24
"Procedure Not Related" Adverse Event	0.47

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from surgery date until 1 year post-operation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ConforMIS iTotal Knee With iPoly Insert

Serious: 15/49 (31%)

Deaths: 1/49

Serious adverse events (6 terms)

Reaction	System	ConforMIS iTotal Knee With…
Hospitalization	General disorders	—
Medical Intervention	General disorders	—
Life-threatening	General disorders	—
Death	Congenital, familial and genetic disorders	—
Other	General disorders	—
Disability	General disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	ConforMIS iTotal Knee With…
Pain/Stiffness Complications	General disorders	—
Infection Complications	Infections and infestations	—
Wound Infection	Skin and subcutaneous tissue disorders	—
Thrombotic Complications	Vascular disorders	—

Most-reported serious reactions: Hospitalization, Medical Intervention, Life-threatening, Death, Other, Disability.

Data from ClinicalTrials.gov NCT03289754 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.