Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee
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ClinicalTrials.gov Identifier: NCT01899417 |
Recruitment Status :
Completed
First Posted : July 15, 2013
Last Update Posted : June 19, 2015
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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 or disease | Intervention/treatment |
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Osteoarthritis,Knee | Device: ConforMIS iTotal® Knee Replacement |
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 |
Actual Enrollment : | 235 participants |
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 |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Group/Cohort | Intervention/treatment |
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ConforMIS iTotal® Knee Replacement
knee joint replacement
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Device: ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
Other Names:
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Standard Knee Replacements
knee joint replacement
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Device: ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
Other Names:
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- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT01899417
United States, Florida | |
JFK Medical Center | |
Atlantis, Florida, United States, 33462 |
Principal Investigator: | Gregory Martin, MD | JFK Medical Center |
Responsible Party: | ConforMIS, Inc. |
ClinicalTrials.gov Identifier: | NCT01899417 |
Other Study ID Numbers: |
13-001 |
First Posted: | July 15, 2013 Key Record Dates |
Last Update Posted: | June 19, 2015 |
Last Verified: | June 2015 |
osteoarthritis knee replacement patient-specific economics |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |