Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

Terminated

• Conditions: Osteoarthritis
• Interventions: Device: iUni® Unicompartmental Knee Resurfacing Device

• Registration Number: NCT01117571
• Lead Sponsor: Restor3D

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Primary Completion: 2014-10-30
• Study Completion: 2023-01-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
open label	iUni® Unicompartmental Knee Resurfacing Device	iUni® Unicompartmental Knee Resurfacing Device

Primary Outcome Measures

Name	Time	Method
Knee Society Score	2 years	to assess knee pain and function
WOMAC Osteoarthritis Index	2 years	to assess knee pain and function

Secondary Outcome Measures

Name	Time	Method
Knee Society Score and WOMAC at years 5 and 10 post-implantation	10 years	Patient reported outcomes measuring pain and function
Length of tourniquet time in minutes	6 weeks	how long the tourniquet was on the patient in surgery
Length of hospital stay in hours	6 weeks	How long each patient was in the hospitals from admission to discharge
Annual revision rates at years 1 through 10 post-implantation	10 years	Number of revision rates
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

Trial Locations

Locations (8)

JFK Medical Center; 🇺🇸 Atlantis, Florida, United States

Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility; 🇺🇸 Little Rock, Arkansas, United States

Center for the Knee and Shoulder; 🇺🇸 Monterey, California, United States

S.T.A.R. Orthopaedics; 🇺🇸 La Quinta, California, United States

Great Lakes Bone and Joint; 🇺🇸 Battle Creek, Michigan, United States

Orthopedic Associates of Pittsburgh; 🇺🇸 Monroeville, Pennsylvania, United States

Heekin Clinic; 🇺🇸 Jacksonville, Florida, United States

Advanced Orthopedics and Sports Medicine; 🇺🇸 Cypress, Texas, United States