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A Retrospective Study of the 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: NCT01564654
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Study Description
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Brief Summary:
This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.

Condition or disease Intervention/treatment
Osteoarthritis Device: iTotal KRS

Study Design
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Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective, Multi-Center Study to Evaluate the ConforMIS iTotal® CR (Cruciate Retaining) Total Knee Replacement System
Study Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
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Group/Cohort Intervention/treatment
iTotal KRS Device: iTotal KRS
Total Knee Replacement System


Outcome Measures
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Primary Outcome Measures :
  1. Knee Function [ Time Frame: Average of 7 months post-operative ]
    Range of Motion


Secondary Outcome Measures :
  1. Revision Rate [ Time Frame: Average of 7 months ]
    Number of knees that required a reoperation to remove/replace/add implant components

  2. Number of Transfusions [ Time Frame: Initial hospital stay ]
    Number of knees that required a blood transfusion during the initial hospital stay post-operative

  3. Manipulations Under Anesthesia [ Time Frame: Up to 7 months post-operative ]
    Number of knees that required a subsequent procedure to restore knee range of motion


Eligibility Criteria
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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 who have received an iTotal Knee replacement
Criteria

Inclusion Criteria:

  1. Clinical condition included in the approved Indications For Use
  2. Has signed the informed consent form to allow review of medical records and collection of data therein.
  3. > 18 years of age

Exclusion Criteria:

  1. Treatment with iTotal in a manner inconsistent with Instructions for Use
  2. Unwilling to sign then informed consent form
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): NCT01564654


Locations
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United States, California
STAR Orthopedics
La Quinta, California, United States, 92253
United States, Florida
Preferred Orthopedics of the Palm Beaches
Boynton Beach, Florida, United States, 33437
United States, Tennessee
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States, 37203
United States, Utah
Central Utah Clinic
Provo, Utah, United States, 84604
Sponsors and Collaborators
ConforMIS, Inc.
More Information
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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01564654    
Other Study ID Numbers: CCP 11-002
First Posted: March 28, 2012    Key Record Dates
Results First Posted: January 20, 2021
Last Update Posted: January 20, 2021
Last Verified: December 2020
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases