We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01117571
First Posted: May 5, 2010
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ConforMIS, Inc.
  Purpose
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 Intervention
Osteoarthritis Device: iUni® Unicompartmental Knee Resurfacing Device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device

Resource links provided by NLM:


Further study details as provided by ConforMIS, Inc.:

Primary Outcome Measures:
  • Knee Society Score [ Time Frame: 2 years ]
    to assess knee pain and function

  • WOMAC Osteoarthritis Index [ Time Frame: 2 years ]
    to assess knee pain and function


Secondary Outcome Measures:
  • Knee Society Score and WOMAC at years 5 and 10 post-implantation [ Time Frame: 10 years ]
    Patient reported outcomes measuring pain and function

  • Annual revision rates at years 1 through 10 post-implantation [ Time Frame: 10 years ]
    Number of revision rates

  • 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

  • Length of tourniquet time in minutes [ Time Frame: 6 weeks ]
    how long the tourniquet was on the patient in surgery

  • Length of hospital stay in hours [ Time Frame: 6 weeks ]
    How long each patient was in the hospitals from admission to discharge


Enrollment: 120
Actual Study Start Date: April 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117571


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     History of Changes
Other Study ID Numbers: 09-001
First Submitted: May 4, 2010
First Posted: May 5, 2010
Last Update Posted: September 20, 2017
Last Verified: September 2017
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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