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This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.
This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities with which the subjects are familiar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTotal PS KRS | Patients who have had an iTotal (posterior stabilized) knee replacement at least 6 months prior to testing. |
| |
| Off-the-Shelf KRS | Patients who have had an off-the-shelf (posterior stabilized) knee replacement at least 6 months prior to testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTotal PS Knee Replacement System | Device | Total Knee Replacement systems (Patient Specific) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional testing differences | Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants | At least 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Clinical Rating Score | Comparison of scores and sub-scores from the following questionnaires between the study arms | At least 6 months post-surgery |
| The Knee Injury and Osteoarthritis Outcome Score (KOOS) |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include a 1:1 ratio of patients enrolled into both the iTotal arm and the off-the-shelf total knee arm.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cannova, MD | Bethesda Orthopedic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bethesda Orthopedic | Bethesda | Maryland | 20817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 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. |
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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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| Off-the-Shelf Knee Replacement System | Device | Total Knee Replacement systems (Off-the-shelf) |
|
Comparison of scores and sub-scores from the following questionnaires between the study arms
| At least 6 months post-surgery |
| 9597060 | Background | Lepage C, Noreau L, Bernard PM. Association between characteristics of locomotion and accomplishment of life habits in children with cerebral palsy. Phys Ther. 1998 May;78(5):458-69. doi: 10.1093/ptj/78.5.458. |
| 14722348 | Background | McCarthy CJ, Oldham JA. The reliability, validity and responsiveness of an aggregated locomotor function (ALF) score in patients with osteoarthritis of the knee. Rheumatology (Oxford). 2004 Apr;43(4):514-7. doi: 10.1093/rheumatology/keh081. Epub 2004 Jan 13. |
| 20851566 | Background | Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20. |
| 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. |
| 16649889 | Background | Nordin E, Rosendahl E, Lundin-Olsson L. Timed "Up & Go" test: reliability in older people dependent in activities of daily living--focus on cognitive state. Phys Ther. 2006 May;86(5):646-55. |
| 1991946 | Background | Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. |
| 20192137 | Background | Suda AJ, Seeger JB, Bitsch RG, Krueger M, Clarius M. Are patients' expectations of hip and knee arthroplasty fulfilled? A prospective study of 130 patients. Orthopedics. 2010 Feb;33(2):76-80. doi: 10.3928/01477447-20100104-07. |
| 10847578 | Background | Wall JC, Bell C, Campbell S, Davis J. The Timed Get-up-and-Go test revisited: measurement of the component tasks. J Rehabil Res Dev. 2000 Jan-Feb;37(1):109-13. |
| 17057533 | Background | Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A. |