Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

Sponsor

ConforMIS, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01117571

Collaborator

(none)

120

Enrollment

Locations

152.4

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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	Phase
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 :

Apr 1, 2010

Actual Primary Completion Date :

Oct 30, 2014

Anticipated Study Completion Date :

Dec 14, 2022

Arms and Interventions

Arm	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

Arm

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

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

Knee Society Score and WOMAC at years 5 and 10 post-implantation [10 years]
Patient reported outcomes measuring pain and function
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical condition included in the approved Indications For Use
Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
18 years of age

Exclusion Criteria:

Simultaneous bilateral procedure required
BMI > 35
Treatment for cancer within the past 5 years, with the exception of skin cancer
Poorly controlled diabetes
Neuromuscular conditions which prevent patient from participating in study activities
Active local or systemic infection
Immunocompromised
Fibromyalgia or other general body pain related condition
Advanced tricompartmental osteoarthritis
Symptomatic patellofemoral disease
Rheumatoid arthritis or other forms of inflammatory joint disease
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
Advanced loss of osteochondral structure on the affected femoral condyle
Compromised ACL, PCL or collateral ligament
Severe (>15º) fixed valgus or varus deformity
Extension deficit > 15 º
Prior history of failed implant surgery of the joint to be treated
Unwilling or unable to comply with study requirements
Participation in another clinical study which would confound results

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Specialty Orthopaedics & HipKneeArkansas Foundation for the Facility	Little Rock	Arkansas	United States	72205
2	S.T.A.R. Orthopaedics	La Quinta	California	United States	92253
3	Center for the Knee and Shoulder	Monterey	California	United States	93940
4	JFK Medical Center	Atlantis	Florida	United States	33462
5	Heekin Clinic	Jacksonville	Florida	United States	32204
6	Great Lakes Bone and Joint	Battle Creek	Michigan	United States	49015
7	Orthopedic Associates of Pittsburgh	Monroeville	Pennsylvania	United States	15146
8	Advanced Orthopedics and Sports Medicine	Cypress	Texas	United States	77429