Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.
ClinicalTrials.gov Identifier:
NCT01117571
First received: May 4, 2010
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Device: iUni® Unicompartmental Knee Resurfacing Device
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ] [ Designated as safety issue: No ]
    to assess knee pain and function

  • WOMAC [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    to assess knee pain and function


Secondary Outcome Measures:
  • Pain and function at years 5 and 10 post-implantation [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Annual revision rates at years 1 through 10 post-implantation [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Incidence of major procedure-related and device-related complications [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Post-operative limb alignment [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Radiographic implant position [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Length of tourniquet time in minutes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Length of hospital stay in hours [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Additional health economics data [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms 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:

See eligibility criteria

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01117571     History of Changes
Other Study ID Numbers: CCP 09-001
Study First Received: May 4, 2010
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ConforMIS, Inc.:
knee
osteoarthritis
unicompartmental
arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014