Trial Outcomes & Findings for A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts (NCT NCT03289754)

NCT ID: NCT03289754

Last Updated: 2025-10-16

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2025-10-16

Participant Flow

Participant milestones

Measure	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. 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.
Overall Study STARTED	52
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

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. 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.

Overall Study Screen Failure or Failure to Meet Follow-up

3

Baseline Characteristics

The age of one patient who met screening criteria and follow-up duration did not have age reported.

Baseline characteristics by cohort

Measure	ConforMIS iTotal Knee With iPoly Insert n=49 Participants The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts. 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.
Age, Continuous	66.27 years n=48 Participants • The age of one patient who met screening criteria and follow-up duration did not have age reported.
Sex: Female, Male Female	30 Participants n=48 Participants • One patient who met screening criteria and follow-up duration did not report sex.
Sex: Female, Male Male	18 Participants n=48 Participants • One patient who met screening criteria and follow-up duration did not report sex.
Region of Enrollment Germany	49 participants n=49 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	"Device Probably Related" Adverse Event n=49 Participants Category of adverse event assigned by the care team indicating the likelihood of specific adverse events being considered "Device Probably Related". Then, converted to "Event per Patient" to allow for simple comparison across different categories.	"Device Possibly Related" Adverse Event n=49 Participants Category of adverse event assigned by the care team indicating the likelihood of specific adverse events being considered "Device Possibly Related". Then, converted to "Event per Patient" to allow for simple comparison across different categories.	"Device All Related" Adverse Event n=49 Participants Category of adverse event assigned by the care team indicating the likelihood of specific adverse events being considered "Device All Related". Then, converted to "Event per Patient" to allow for simple comparison across different categories.	"Device Not Related" Adverse Event n=49 Participants Category of adverse event assigned by the care team indicating the likelihood of specific adverse events being considered "Device Not Related". Then, converted to "Event per Patient" to allow for simple comparison across different categories.
Incidence of Device-related Complications	0.02 Events per Patient	0.31 Events per Patient	0.33 Events per Patient	0.39 Events per Patient

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	"Device Probably Related" Adverse Event n=49 Participants Category of adverse event assigned by the care team indicating the likelihood of specific adverse events being considered "Device Probably Related". Then, converted to "Event per Patient" to allow for simple comparison across different categories.	"Device Possibly Related" Adverse Event n=49 Participants Category of adverse event assigned by the care team indicating the likelihood of specific adverse events being considered "Device Possibly Related". Then, converted to "Event per Patient" to allow for simple comparison across different categories.	"Device All Related" Adverse Event n=49 Participants Category of adverse event assigned by the care team indicating the likelihood of specific adverse events being considered "Device All Related". Then, converted to "Event per Patient" to allow for simple comparison across different categories.	"Device Not Related" Adverse Event n=49 Participants Category of adverse event assigned by the care team indicating the likelihood of specific adverse events being considered "Device Not Related". Then, converted to "Event per Patient" to allow for simple comparison across different categories.
Incidence of Procedure-Related Complications	0.1 Events per Patient	0.14 Events per Patient	0.24 Events per Patient	0.47 Events per Patient

Adverse Events

ConforMIS iTotal Knee With iPoly Insert

Serious events: 15 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Measure	ConforMIS iTotal Knee With iPoly Insert n=49 participants at risk The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts. 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.
Congenital, familial and genetic disorders Death	2.0% 1/49 • Number of events 1 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov
General disorders Life-threatening	4.1% 2/49 • Number of events 2 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov
General disorders Disability	0.00% 0/49 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov
General disorders Medical Intervention	10.2% 5/49 • Number of events 7 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov
General disorders Hospitalization	14.3% 7/49 • Number of events 9 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov
General disorders Other	2.0% 1/49 • Number of events 1 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov

Other adverse events

Measure	ConforMIS iTotal Knee With iPoly Insert n=49 participants at risk The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts. 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.
Infections and infestations Infection Complications	6.1% 3/49 • Number of events 3 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov
Skin and subcutaneous tissue disorders Wound Infection	4.1% 2/49 • Number of events 2 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov
Vascular disorders Thrombotic Complications	2.0% 1/49 • Number of events 1 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov
General disorders Pain/Stiffness Complications	12.2% 6/49 • Number of events 9 • Adverse Events were collected from surgery date until 1 year post-operation. N/A. All reporting followed the definitions on clinicaltrials.gov

Additional Information

Director of Clinical Affairs

restor3d, Inc.

Phone: (984) 888-0593

Email: clinicalresearch@restor3d.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place