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

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.
 
ClinicalTrials.gov Identifier: NCT01820650
Recruitment Status : Active, not recruiting
First Posted : March 29, 2013
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Study Description
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Brief Summary:
This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

Condition or disease Intervention/treatment
Osteoarthritis of the Knee Device: iTotal G2 CR Knee Replacement System

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.
Study Design
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Study Type : Observational
Actual Enrollment : 359 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Actual Study Start Date : February 2013
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: iTotal G2 CR Knee Replacement System
    Total Knee replacement

Outcome Measures
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Primary Outcome Measures :
  1. 2011 Knee Society Score [ Time Frame: 1 Year ]

Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with osteoarthritis of the knee
Criteria

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
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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): NCT01820650


Locations
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United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
United States, Maine
EMMC - Orthopaedic Surgery of Maine
Bangor, Maine, United States, 04401
United States, Michigan
Great Lakes Bone and Joint
Battle Creek, Michigan, United States, 49015
United States, Nevada
Orthopaedic Instatute of Henderson
Henderson, Nevada, United States, 89052
Desert Orthopedic Center
Las Vegas, Nevada, United States, 89121
United States, Tennessee
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States, 37203
United States, Texas
Advanced Orthopedics and Sports Medicine
Cypress, Texas, United States, 77429
Joint Replacement Associates
Houston, Texas, United States, 77030
United States, Vermont
Mansfield Orthopaedics
Morrisville, Vermont, United States, 05661
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
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Study Director: Marc Quartulli ConforMIS, Inc.
Principal Investigator: Terry Clyburn, MD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01820650    
Other Study ID Numbers: 12-001
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by ConforMIS, Inc.:
osteoarthritis
knee replacement
patient-specific
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases