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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ConforMIS iTotal® Knee Replacement | knee joint replacement |
| |
| Standard Knee Replacements | knee joint replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ConforMIS iTotal® Knee Replacement | Device | Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have had a Total Knee Replacement performed by the Investigator and are at least 3 months post surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Martin, MD | JFK Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JFK Medical Center | Atlantis | Florida | 33462 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17403800 | Background | 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. | |
| 1959265 | Background | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| 17188876 | Background | 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. |
| 19182028 | Background | 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. |
| 19844772 | Background | 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. |
| 16967035 | Background | 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. |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |