Clinical trial NCT01117571: Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant
Official title: A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Keywords: knee
osteoarthritis
unicompartmental
arthroplasty
knee resurfacing
Conformis
patient specific
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 who have uni-compartmental osteoarthritis to be treated with a unilateral knee resurfacing procedure

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Score
timeFrame: 2 years
measure: WOMAC Osteoarthritis Index
timeFrame: 2 years
Secondary outcomes:
measure: Knee Society Score and WOMAC at years 5 and 10 post-implantation
timeFrame: 10 years
measure: Annual revision rates at years 1 through 10 post-implantation
timeFrame: 10 years
measure: Incidence of major procedure-related and device-related complications
timeFrame: 10 years
measure: Length of tourniquet time in minutes
timeFrame: 6 weeks
measure: Length of hospital stay in hours
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility
state: Arkansas
city: La Quinta
country: United States
facility: S.T.A.R. Orthopaedics
state: California
city: Monterey
country: United States
facility: Center for the Knee and Shoulder
state: California
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Heekin Clinic
state: Florida
city: Battle Creek
country: United States
facility: Great Lakes Bone and Joint
state: Michigan
city: Monroeville
country: United States
facility: Orthopedic Associates of Pittsburgh
state: Pennsylvania
city: Cypress
country: United States
facility: Advanced Orthopedics and Sports Medicine
state: Texas
Study officials:
affiliation: Hip Knee Arkansas Foundation
name: C. Lowry Barnes, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Restor3D
name: Marc Quartulli
role: STUDY_DIRECTOR
References: