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

Osteoarthritis,Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899417
• Other study ID #: 13-001
• Status: Completed
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis,Knee

Intervention

Device:
• ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.

Locations

Country	Name	City	State
United States	JFK Medical Center	Atlantis	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. doi: 10.1016/j.knee.2006.11.005. Epub 2006 Dec 22. — View Citation

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. doi: 10.2106/JBJS.F.00222. — View Citation

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. doi: 10.1097/01.blo.0000238825.63648.1e. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op	Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op	1 month
Primary	Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op	Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op	3 months