Not provided
Not provided
Not provided
Not provided
Not provided
Decision of investigational team
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ConforMIS iTotal Knee with iPoly Insert | Experimental | The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philipp Drees | University- Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of Johannes Gutenberg-University Mainz | Mainz | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study terminated early.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age of one patient who met screening criteria and follow-up duration did not have age reported. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Events per Patient | 1 year |
|
Adverse Events were collected from surgery date until 1 year post-operation.
N/A. All reporting followed the definitions on clinicaltrials.gov
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Congenital, familial and genetic disorders | Non-systematic Assessment | Serious Adverse Event listed as "SAE_DEATH" by investigators |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection Complications | Infections and infestations | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | restor3d, Inc. | (984) 888-0593 | clinicalresearch@restor3d.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2016 | Aug 22, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | One patient who met screening criteria and follow-up duration did not report sex. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| "Device Possibly Related" Adverse Event |
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. |
| OG002 | "Device All Related" Adverse Event | 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. |
| OG003 | "Device Not Related" Adverse Event | 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. |
|
|
| Primary | 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. | Posted | Number | Events per Patient | 1 year |
|
|
|
| 1 |
| 49 |
| 15 |
| 49 |
| 12 |
| 49 |
|
| Life-threatening | General disorders | Non-systematic Assessment | Events that posed an immediate risk to the patient's life requiring urgent intervention |
|
| Disability | General disorders | Non-systematic Assessment | Events that resulted in persistent or significant disability or incapacity |
|
| Medical Intervention | General disorders | Non-systematic Assessment | Events that required medical or surgical intervention to prevent death, life-threatening situations, or permanent disability. |
|
| Hospitalization | General disorders | Non-systematic Assessment | Events that required inpatient hospitalization or prolonged existing hospitalization but did not meet other severity criteria |
|
| Other | General disorders | Non-systematic Assessment | Serious adverse events that did not fit into standard severity categories or had incomplete severity documentation |
|
| Wound Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Thrombotic Complications | Vascular disorders | Non-systematic Assessment |
|
| Pain/Stiffness Complications | General disorders | Non-systematic Assessment |
|
Not provided
Not provided