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

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

Study Description

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.

Condition or disease	Intervention/treatment
Osteoarthritis,Knee	Device: ConforMIS iTotal® Knee Replacement

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 Design

• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

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

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:

Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5.

Rougraff BT, Heck DA, Gibson AE. A comparison of tricompartmental and unicompartmental arthroplasty for the treatment of gonarthrosis. Clin Orthop Relat Res. 1991 Dec;(273):157-64.

Fitzpatrick C, FitzPatrick D, Lee J, Auger D. Statistical design of unicompartmental tibial implants and comparison with current devices. Knee. 2007 Mar;14(2):138-44. Epub 2006 Dec 22.

Fitz W. Unicompartmental knee arthroplasty with use of novel patient-specific resurfacing implants and personalized jigs. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:69-76. doi: 10.2106/JBJS.H.01448.

Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.

Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43.

• Responsible Party: ConforMIS, Inc.
• ClinicalTrials.gov Identifier: NCT01899417
• Other Study ID Numbers: 13-001
• First Posted: July 15, 2013
• Last Update Posted: June 19, 2015
• Last Verified: June 2015

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