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

Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01899417

Enrollment

235

Registered

2013-07-15

Start date

2013-07-31

Completion date

2014-03-31

Last updated

2023-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis,Knee

Keywords

osteoarthritis, knee replacement, patient-specific, economics

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.

Interventions

DEVICEConforMIS iTotal® Knee Replacement

Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op	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	3 months	Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026