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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.
ClinicalTrials.gov Identifier:
NCT01899417
First received: July 9, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Osteoarthritis,Knee
Device: ConforMIS iTotal® Knee Replacement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee

Resource links provided by NLM:


Further study details as provided by ConforMIS, Inc.:

Primary Outcome Measures:
  • Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op


Estimated Enrollment: 240
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ConforMIS iTotal® Knee Replacement
knee joint replacement
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
Standard Knee Replacements
knee joint replacement
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899417

Locations
United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
Principal Investigator: Gregory Martin, MD JFK Medical Center
  More Information

Publications:
Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT01899417     History of Changes
Other Study ID Numbers: CCP 13-001
Study First Received: July 9, 2013
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ConforMIS, Inc.:
osteoarthritis
knee replacement
patient-specific
economics

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

ClinicalTrials.gov processed this record on October 02, 2014