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Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee

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: NCT01899417
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Tracking Information
First Submitted Date July 9, 2013
First Posted Date July 15, 2013
Last Update Posted Date June 19, 2015
Study Start Date July 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2013)
  • Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op [ Time Frame: 1 month ]
    Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
  • Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op [ Time Frame: 3 months ]
    Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee
Official Title Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee
Brief Summary

The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal® total knee replacement system versus standard total knee arthroplasty.

This study is designed to illustrate the difference in cost between standard total knee replacements and the ConforMIS iTotal at a single institution.

Detailed Description

STUDY DESIGN The study is a two-arm single-center, consecutively enrolled retrospective study. Patients enrolled will have previously received either an iTotal CR knee replacement or a standard total knee replacement. The study site will be located in the United States. A minimum of 100 with a maximum of 120 patients will be enrolled in each study arm for a maximum of 200 - 240 patients.

STUDY DURATION This study involves retrospective data collection of operative and peri-operative information to determine the cost impact of several surgical variables. The study will be complete when the retrospective data has been collected on up to 120 patients per arm.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have had a Total Knee Replacement performed by the Investigator and are at least 3 months post surgery.
Condition Osteoarthritis,Knee
Intervention Device: ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
Other Names:
  • Total knee replacement
  • arthoplasty
  • TKA
  • iTotal
  • Standard total knee device
Study Groups/Cohorts
  • ConforMIS iTotal® Knee Replacement
    knee joint replacement
    Intervention: Device: ConforMIS iTotal® Knee Replacement
  • Standard Knee Replacements
    knee joint replacement
    Intervention: Device: ConforMIS iTotal® Knee Replacement
Publications *

*   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: April 9, 2015)
235
Original Estimated Enrollment
 (submitted: July 12, 2013)
240
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient has received an iTotal or a standard total knee replacement
  • Willingness to participate in the clinical study and to give informed consent, if necessary, as determined during IRB review
  • >18 years of age

Exclusion Criteria:

  • Participation in another clinical study that could confound results
  • Patient is less than 3 months post-op
Sex/Gender
Sexes Eligible for Study: All
Ages 19 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 NCT01899417
Other Study ID Numbers 13-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ConforMIS, Inc.
Study Sponsor ConforMIS, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Gregory Martin, MD JFK Medical Center
PRS Account ConforMIS, Inc.
Verification Date June 2015