Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

Osteoarthritis Clinical Trial

— iUni  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01117571
• Other study ID #: 09-001
• Status: Terminated
• Start date: April 2010
• Est. completion date: January 10, 2023

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: January 10, 2023
• Est. primary completion date: October 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	JFK Medical Center	Atlantis	Florida
United States	Great Lakes Bone and Joint	Battle Creek	Michigan
United States	Advanced Orthopedics and Sports Medicine	Cypress	Texas
United States	Heekin Clinic	Jacksonville	Florida
United States	S.T.A.R. Orthopaedics	La Quinta	California
United States	Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility	Little Rock	Arkansas
United States	Orthopedic Associates of Pittsburgh	Monroeville	Pennsylvania
United States	Center for the Knee and Shoulder	Monterey	California

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score	to assess knee pain and function	2 years
Primary	WOMAC Osteoarthritis Index	to assess knee pain and function	2 years
Secondary	Knee Society Score and WOMAC at years 5 and 10 post-implantation	Patient reported outcomes measuring pain and function	10 years
Secondary	Annual revision rates at years 1 through 10 post-implantation	Number of revision rates	10 years
Secondary	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
Secondary	Length of tourniquet time in minutes	how long the tourniquet was on the patient in surgery	6 weeks
Secondary	Length of hospital stay in hours	How long each patient was in the hospitals from admission to discharge	6 weeks