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Completed

NCT Number: NCT01899417

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

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.

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Key information

Conditions

Osteoarthritis,Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

JFK Medical Center

Atlantis, Florida, 33462, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ConforMIS iTotal® Knee Replacement

Device

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Restor3D

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2013
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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