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A Retrospective Study of the iTotal CR Knee Replacement System

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ClinicalTrials.gov Identifier: NCT01564654
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

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 Traumatic Osteoarthritis Device: iTotal KRS

Study Type : Observational
Actual Enrollment : 106 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

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




Primary Outcome Measures :
  1. Knee Function [ Time Frame: Average of 3-6 months ]
    Includes range of motion


Secondary Outcome Measures :
  1. Revision Rate [ Time Frame: Average of 3-6 months ]
  2. Knee Pain [ Time Frame: Average of 3-6 months ]
  3. Post-operative Limb Alignment [ Time Frame: Average of 3-6 months ]
  4. Total Surgical Time [ Time Frame: Day of surgery ]
  5. Estimated Blood Loss [ Time Frame: Day of surgery ]
  6. Surgical Complications [ Time Frame: Day of Surgery ]
  7. Length of Hospital Stay [ Time Frame: At Discharge (approx 2-5 days from surgery) ]


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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

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
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.

Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01564654     History of Changes
Other Study ID Numbers: CCP 11-002
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013

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