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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
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Tracking Information
First Submitted Date March 26, 2012
First Posted Date March 28, 2012
Last Update Posted Date April 19, 2013
Study Start Date January 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2012)
Knee Function [ Time Frame: Average of 3-6 months ]
Includes range of motion
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 27, 2012)
  • Revision Rate [ Time Frame: Average of 3-6 months ]
  • Knee Pain [ Time Frame: Average of 3-6 months ]
  • Post-operative Limb Alignment [ Time Frame: Average of 3-6 months ]
  • Total Surgical Time [ Time Frame: Day of surgery ]
  • Estimated Blood Loss [ Time Frame: Day of surgery ]
  • Surgical Complications [ Time Frame: Day of Surgery ]
  • Length of Hospital Stay [ Time Frame: At Discharge (approx 2-5 days from surgery) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Study of the iTotal CR Knee Replacement System
Official Title A Retrospective, Multi-Center Study to Evaluate the ConforMIS iTotal® CR (Cruciate Retaining) Total Knee Replacement System
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have received an iTotal Knee replacement
Condition
  • Osteoarthritis
  • Traumatic Osteoarthritis
Intervention Device: iTotal KRS
Total Knee Replacement System
Study Groups/Cohorts iTotal KRS
Intervention: Device: iTotal KRS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 26, 2013)
106
Original Estimated Enrollment
 (submitted: March 27, 2012)
100
Actual Study Completion Date January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01564654
Other Study ID Numbers CCP 11-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ConforMIS, Inc.
Study Sponsor ConforMIS, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account ConforMIS, Inc.
Verification Date April 2013