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

• ClinicalTrials.gov Identifier: NCT01117571
• Recruitment Status: Unknown
• First Posted: May 5, 2010
• Last Update Posted: November 18, 2020
• Sponsor: ConforMIS, Inc.
• Information provided by (Responsible Party): ConforMIS, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Osteoarthritis	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 Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device
• Actual Study Start Date: April 2010
• Actual Primary Completion Date: October 30, 2014
• Estimated Study Completion Date: December 14, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Knee Society Score [ Time Frame: 2 years ]
   to assess knee pain and function
2. WOMAC Osteoarthritis Index [ Time Frame: 2 years ]
   to assess knee pain and function

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Contacts and Locations

Locations

United States, Arkansas

Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility

Little Rock, Arkansas, United States, 72205

United States, California

S.T.A.R. Orthopaedics

La Quinta, California, United States, 92253

Center for the Knee and Shoulder

Monterey, California, United States, 93940

United States, Florida

JFK Medical Center

Atlantis, Florida, United States, 33462

Heekin Clinic

Jacksonville, Florida, United States, 32204

United States, Michigan

Great Lakes Bone and Joint

Battle Creek, Michigan, United States, 49015

United States, Pennsylvania

Orthopedic Associates of Pittsburgh

Monroeville, Pennsylvania, United States, 15146

United States, Texas

Advanced Orthopedics and Sports Medicine

Cypress, Texas, United States, 77429

Sponsors and Collaborators

ConforMIS, Inc.

Investigators

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

More Information

• Responsible Party: ConforMIS, Inc.
• ClinicalTrials.gov Identifier: NCT01117571
• Other Study ID Numbers: 09-001
• First Posted: May 5, 2010
• Last Update Posted: November 18, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by ConforMIS, Inc.:

knee; osteoarthritis; unicompartmental; arthroplasty; knee resurfacing; Conformis; patient specific

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases