Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant (iUni)

A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: iUni® Unicompartmental Knee Resurfacing Device

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility
  • California
    • La Quinta, California, United States, 92253
      • S.T.A.R. Orthopaedics
    • Monterey, California, United States, 93940
      • Center for the Knee and Shoulder
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Jacksonville, Florida, United States, 32204
      • Heekin Clinic
  • Michigan
    • Battle Creek, Michigan, United States, 49015
      • Great Lakes Bone and Joint
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • Orthopedic Associates of Pittsburgh
  • Texas
    • Cypress, Texas, United States, 77429
      • Advanced Orthopedics and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 who have uni-compartmental osteoarthritis to be treated with a unilateral knee resurfacing procedure

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

open label; iUni® Unicompartmental Knee Resurfacing Device

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score	to assess knee pain and function	2 years
WOMAC Osteoarthritis Index	to assess knee pain and function	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score and WOMAC at years 5 and 10 post-implantation	Patient reported outcomes measuring pain and function	10 years
Annual revision rates at years 1 through 10 post-implantation	Number of revision rates	10 years
Incidence of major procedure-related and device-related complications	rate of incidence of serious adverse events that are related to the device or the procedure	10 years
Length of tourniquet time in minutes	how long the tourniquet was on the patient in surgery	6 weeks
Length of hospital stay in hours	How long each patient was in the hospitals from admission to discharge	6 weeks

Collaborators and Investigators

• Sponsor: Restor3D
• Investigators: Principal Investigator: C. Lowry Barnes, M.D, Hip Knee Arkansas Foundation; Study Director: Marc Quartulli, Restor3D

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): October 30, 2014
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimated): May 5, 2010

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; unicompartmental; arthroplasty; knee resurfacing; Conformis; patient specific
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 09-001 (SIUH IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes