An interventional study of iPoly XE tibial insert with ConforMIS iTotal KRS in Knee Osteoarthritis, sponsored by Restor3D. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by Restor3D · Not applicable, Interventional, and Basic science
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.
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 52 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Restor3D is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts.
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.
Incidence of Device-related Complications
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.
Time frame: 1 year
Incidence of Procedure-Related Complications
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.
Time frame: 1 year
| Milestone | ConforMIS iTotal Knee With iPoly Insert |
|---|---|
| Started | 52 |
| Completed | 49 |
| Not completed | 3 |
| Withdrew: Screen failure or failure to meet follow-up | 3 |
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.
| Events per Patient | "Device Probably Related" Adverse Event | "Device Possibly Related" Adverse Event | "Device All Related" Adverse Event | "Device Not Related" Adverse Event |
|---|---|---|---|---|
| Incidence of Device-related Complications | 0.02 | 0.31 | 0.33 | 0.39 |
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.
| Events per Patient | "Procedure Probably Related" Adverse Event | "Procedure Possibly Related" Adverse Event | "Procedure All Related" Adverse Event | "Procedure Not Related" Adverse Event |
|---|---|---|---|---|
| Incidence of Procedure-Related Complications | 0.1 | 0.14 | 0.24 | 0.47 |
Collected over Adverse Events were collected from surgery date until 1 year post-operation.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ConforMIS iTotal Knee With iPoly Insert | 1/49 (2%) | 15/49 (30.6%) | 12/49 (24.5%) |
| Event | ConforMIS iTotal Knee With iPoly Insert |
|---|---|
| HospitalizationGeneral disorders | 7/49 |
| Medical InterventionGeneral disorders | 5/49 |
| Life-threateningGeneral disorders | 2/49 |
| DeathCongenital, familial and genetic disorders | 1/49 |
| OtherGeneral disorders | 1/49 |
| DisabilityGeneral disorders | 0/49 |
| Event | ConforMIS iTotal Knee With iPoly Insert |
|---|---|
| Pain/Stiffness ComplicationsGeneral disorders | 6/49 |
| Infection ComplicationsInfections and infestations | 3/49 |
| Wound InfectionSkin and subcutaneous tissue disorders | 2/49 |
| Thrombotic ComplicationsVascular disorders | 1/49 |
Study terminated early.
| Age, Continuous(years) | ConforMIS iTotal Knee With iPoly Insert |
|---|---|
| Mean | 66.27 (45 to 87) |
| Sex: Female, Male(Participants) | ConforMIS iTotal Knee With iPoly Insert |
|---|---|
| Female | 30 |
| Male | 18 |
| Race and Ethnicity Not Collected(Participants) | ConforMIS iTotal Knee With iPoly Insert |
|---|
| Region of Enrollment(participants) | ConforMIS iTotal Knee With iPoly Insert |
|---|---|
| Germany | 49 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2022, 52 months.
Results were first posted in Oct 2025, 3 years 4 months after primary completion.
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This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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