A Retrospective Study to Evaluate the ConforMIS iUni, iDuo & iTotal® KRS
NCT ID: NCT03152357
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
950 participants
OBSERVATIONAL
2017-04-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients implanted with a ConforMIS device
Previously underwent surgical implantation of a ConforMIS iUni, iDuo or iTotal knee replacement
ConforMIS iUni, iDuo, or iTotal (CR)
ConforMIS iUni, iDuo, or iTotal (CR)
Interventions
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ConforMIS iUni, iDuo, or iTotal (CR)
ConforMIS iUni, iDuo, or iTotal (CR)
Eligibility Criteria
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Inclusion Criteria
* Subject must be greater than 18 years of age.
18 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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Preferred Orthopedics of the Palm Beaches
Boynton Beach, 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.
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.
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.
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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16-003
Identifier Type: -
Identifier Source: org_study_id
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