Osteoarthritis
Conditions
Keywords
knee, osteoarthritis, unicompartmental, arthroplasty, knee resurfacing, Conformis, patient specific
Brief summary
Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.
Detailed description
The iUni G2 Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The study subjects will be followed for 10 years post implant. The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis. The iUni is a patient-specific unicompartmental resurfacing device designed from the patient's unique anatomy using proprietary software which interprets data from the patient's CT scan. The patient matched implant design is then coupled with unique patient-matched disposable instrumentation designed using the same CT data and software. The follow-up visit schedule will include visits at 6 weeks, 6 months (optional), 1 year, 2 years, 5 years and 10 years post implant.The remaining follow-up data collected at years 3, 4, 6, 7, 8, and 9 may be collected via phone call/email and does not require a subject visit to the site.The study sites will be located in the United States.
Interventions
DEVICEiUni® Unicompartmental Knee Resurfacing Device
The iUni® Unicompartmental Resurfacing Device is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation
Sponsors
Restor3D
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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 2. Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment 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 \> 35 3. Treatment for cancer within the past 5 years, with the exception of skin cancer 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. Advanced tricompartmental osteoarthritis 10. Symptomatic patellofemoral disease 11. Rheumatoid arthritis or other forms of inflammatory joint disease 12. Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified 13. Advanced loss of osteochondral structure on the affected femoral condyle 14. Compromised ACL, PCL or collateral ligament 15. Severe (\>15º) fixed valgus or varus deformity 16. Extension deficit \> 15 º 17. Prior history of failed implant surgery of the joint to be treated 18. Unwilling or unable to comply with study requirements 19. Participation in another clinical study which would confound results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 2 years | to assess knee pain and function |
| WOMAC Osteoarthritis Index | 2 years | to assess knee pain and function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major procedure-related and device-related complications | 10 years | rate of incidence of serious adverse events that are related to the device or the procedure |
| Knee Society Score and WOMAC at years 5 and 10 post-implantation | 10 years | Patient reported outcomes measuring pain and function |
| Length of hospital stay in hours | 6 weeks | How long each patient was in the hospitals from admission to discharge |
| Length of tourniquet time in minutes | 6 weeks | how long the tourniquet was on the patient in surgery |
| Annual revision rates at years 1 through 10 post-implantation | 10 years | Number of revision rates |
Countries
United States
Outcome results
None listed