Costs and Benefits of ConforMIS iTotal® Knee Replacement System Versus Standard Total Knee
NCT ID: NCT01899417
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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COMPLETED
235 participants
OBSERVATIONAL
2013-07-31
2014-03-31
Brief Summary
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This study is designed to illustrate the difference in cost between standard total knee replacements and the ConforMIS iTotal at a single institution.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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ConforMIS iTotal® Knee Replacement
knee joint replacement
ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
Standard Knee Replacements
knee joint replacement
ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
Interventions
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ConforMIS iTotal® Knee Replacement
Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patient is less than 3 months post-op
19 Years
ALL
No
Sponsors
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Restor3D
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Martin, MD
Role: PRINCIPAL_INVESTIGATOR
JFK Medical Center
Locations
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JFK Medical Center
Atlantis, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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13-001
Identifier Type: -
Identifier Source: org_study_id
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