Clinical trial NCT01899417: Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee
Official title: Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis,Knee
Keywords: osteoarthritis
knee replacement
patient-specific
economics
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2013-07-15
Enrollment: 235
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
timeFrame: 1 month
measure: Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
Study officials:
affiliation: JFK Medical Center
name: Gregory Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
citation: 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.
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.