Knee Osteoarthritis
Conditions
Keywords
knee implant, osteoarthritis, patient-specific, knee osteoarthritis
Brief summary
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.
Detailed description
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.
Interventions
DEVICEiPoly 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.
Sponsors
Restor3D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical condition included in the approved Indications For Use for the iTotal® CR 2. Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment. 3. Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits 4. \> 18 years of age
Exclusion criteria
1. Simultaneous bilateral procedure required 2. BMI \> 40 3. Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years 4. Poorly controlled diabetes 5. Neuromuscular conditions which prevent patient from participating in study activities 6. Active local or systemic infection 7. Immunocompromised 8. Fibromyalgia or other general body pain related condition 9. Rheumatoid arthritis or other forms of inflammatory joint disease 10. Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified 11. Diagnosed with or receiving treatment for Osteoporosis 12. Other physical disability affecting the hips, spine, or contralateral knee 13. Severe instability due to advanced loss of osteochondral structure 14. Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO) 15. Compromised PCL or collateral ligament 16. Severe fixed valgus or varus deformity of \>15º 17. Extensor lag \> 15º 18. Fixed flexion contracture ≥ 15º 19. Unwilling or unable to comply with study requirements 20. Participation in another clinical study which would confound results 21. Allergy to any of the implant materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Procedure-Related Complications | 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. |
| Incidence of Device-related Complications | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure or Failure to Meet Follow-up | 3 |
Baseline characteristics
| Characteristic | ConforMIS iTotal Knee With iPoly Insert | — |
|---|---|---|
| Age, Continuous | 66.27 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 49 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 49 |
| other Total, other adverse events | 12 / 49 |
| serious Total, serious adverse events | 15 / 49 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Probably Related Adverse Event | Incidence of Device-related Complications | 0.02 Events per Patient |
| Device Possibly Related Adverse Event | Incidence of Device-related Complications | 0.31 Events per Patient |
| Device All Related Adverse Event | Incidence of Device-related Complications | 0.33 Events per Patient |
| Device Not Related Adverse Event | Incidence of Device-related Complications | 0.39 Events per Patient |
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Probably Related Adverse Event | Incidence of Procedure-Related Complications | 0.1 Events per Patient |
| Device Possibly Related Adverse Event | Incidence of Procedure-Related Complications | 0.14 Events per Patient |
| Device All Related Adverse Event | Incidence of Procedure-Related Complications | 0.24 Events per Patient |
| Device Not Related Adverse Event | Incidence of Procedure-Related Complications | 0.47 Events per Patient |