A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by ConforMIS, Inc.
Information provided by (Responsible Party):
ConforMIS, Inc.
ClinicalTrials.gov Identifier:
First received: March 26, 2013
Last updated: May 29, 2015
Last verified: May 2015
This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

Condition Intervention
Osteoarthritis of the Knee
Device: iTotal G2 CR Knee Replacement System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System

Resource links provided by NLM:

Further study details as provided by ConforMIS, Inc.:

Primary Outcome Measures:
  • 2011 Knee Society Score [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2013
Estimated Study Completion Date: March 2025
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: iTotal G2 CR Knee Replacement System
    Total Knee replacement
Detailed Description:
If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with osteoarthritis of the knee

Inclusion Criteria:

  • Clinical condition included in the approved Indications For Use for the iTotal® CR
  • Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
  • 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 > 40
  • Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
  • 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
  • Rheumatoid arthritis or other forms of inflammatory joint disease
  • Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
  • Diagnosed with or receiving treatment for Osteoporosis
  • Other physical disability affecting the hips, spine, or contralateral knee.
  • Severe instability due to advanced loss of osteochondral structure
  • Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
  • Compromised PCL or collateral ligament
  • Severe fixed valgus or varus deformity of >15º
  • Extensor lag > 15 º
  • Fixed flexion contracture ≥ 15 º
  • Unwilling or unable to comply with study requirements
  • Participation in another clinical study which would confound results
  • Allergy to any of the implant materials
  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: NCT01820650

United States, Florida
JFK Medical Center Recruiting
Atlantis, Florida, United States, 33462
Contact: Jamie Kosik    561-548-1414    Jamie.Kosik@hcahealthcare.com   
Principal Investigator: Gregory Martin, MD         
United States, Maine
EMMC - Orthopaedic Surgery of Maine Recruiting
Bangor, Maine, United States, 04401
Contact: Krysta Anderson    207-973-4263    keanderson@emhs.org   
Principal Investigator: Ian Dickey, MD         
United States, Michigan
Great Lakes Bone and Joint Recruiting
Battle Creek, Michigan, United States, 49015
Contact: Becky Klein, RN    269-979-2490 ext 129    bklein@brooksidesurgery.com   
Principal Investigator: Joseph Burkhardt, DO         
United States, Nevada
Orthopaedic Instatute of Henderson Recruiting
Henderson, Nevada, United States, 89052
Contact: Brian Bauer    702-565-6565 ext 312    brianb@oihnv.com   
Principal Investigator: Robert Tait, MD         
Desert Orthopedic Center Recruiting
Las Vegas, Nevada, United States, 89121
Contact: Laura Jones    702-731-1616    ljones@doclv.com   
Principal Investigator: Todd Swanson, MD         
United States, Tennessee
Tennessee Orthopaedic Alliance Recruiting
Nashville, Tennessee, United States, 37203
Contact: Katie Vanhooser, PA    615-329-6600    vanhooserkj@toa.com   
Principal Investigator: William Kurtz, MD         
United States, Texas
Advanced Orthopedics and Sports Medicine Recruiting
Cypress, Texas, United States, 77429
Contact: Jacel Brooks, MD    281-955-7577    jbrooks@advancedosm.com   
Principal Investigator: David Mack, MD         
Joint Replacement Associates Recruiting
Houston, Texas, United States, 77030
Contact: Terry Clyburn, MD    713-357-4752      
United States, Vermont
Mansfield Orthopaedics Recruiting
Morrisville, Vermont, United States, 05661
Contact: Leah Morse, MS, PA-C    802-888-8405    lemorse@chsi.org   
Principal Investigator: Bryan Huber, MD         
Sponsors and Collaborators
ConforMIS, Inc.
Study Director: Marc Quartulli ConforMIS, Inc.
Principal Investigator: Terry Clyburn, MD The University of Texas Health Science Center, Houston
  More Information

Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01820650     History of Changes
Other Study ID Numbers: 12-001 
Study First Received: March 26, 2013
Last Updated: May 29, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by ConforMIS, Inc.:
knee replacement

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 27, 2016