A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf
NCT ID: NCT03146819
Last Updated: 2023-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
31 participants
OBSERVATIONAL
2016-12-16
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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iTotal PS KRS
Patients who have had an iTotal (posterior stabilized) knee replacement at least 6 months prior to testing.
iTotal PS Knee Replacement System
Total Knee Replacement systems (Patient Specific)
Off-the-Shelf KRS
Patients who have had an off-the-shelf (posterior stabilized) knee replacement at least 6 months prior to testing.
Off-the-Shelf Knee Replacement System
Total Knee Replacement systems (Off-the-shelf)
Interventions
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iTotal PS Knee Replacement System
Total Knee Replacement systems (Patient Specific)
Off-the-Shelf Knee Replacement System
Total Knee Replacement systems (Off-the-shelf)
Eligibility Criteria
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Inclusion Criteria
* Subject has had a knee replacement utilizing a fixed bearing PS (Posterior Stabilized) implant design
* \> 18 years of age
* Willingness to participate in the clinical study, to give informed consent, and to perform all evaluations
Exclusion Criteria
* BMI \> 40
* Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
* Participation in another clinical study which would confound results
* Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
18 Years
ALL
No
Sponsors
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Restor3D
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Cannova, MD
Role: PRINCIPAL_INVESTIGATOR
Bethesda Orthopedic
Locations
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Bethesda Orthopedic
Bethesda, Maryland, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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15-001
Identifier Type: -
Identifier Source: org_study_id
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