This trial is active, not recruiting.

Condition osteoarthritis
Treatment iuni® unicompartmental knee resurfacing device
Phase phase 4
Sponsor ConforMIS, Inc.
Start date April 2010
End date August 2014
Trial size 120 participants
Trial identifier NCT01117571, 09-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
iUni® Unicompartmental Knee Resurfacing Device
iuni® 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

Primary Outcomes

Knee Society Score
time frame: 2 years
time frame: 2 years

Secondary Outcomes

Pain and function at years 5 and 10 post-implantation
time frame: 10 years
Annual revision rates at years 1 through 10 post-implantation
time frame: 10 years
Incidence of major procedure-related and device-related complications
time frame: 10 years
Post-operative limb alignment
time frame: 10 years
Radiographic implant position
time frame: 6 months
Length of tourniquet time in minutes
time frame: 6 weeks
Length of hospital stay in hours
time frame: 6 weeks
Additional health economics data
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device
Principal investigator C. Lowry Barnes, M.D
Description See eligibility criteria
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by ConforMIS, Inc..