A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Exactech
Study ID
NCT05653102
Status
Recruiting
Apply to this trial

Conditions

  • Knee Arthroplasty, Total

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Truliant Total Knee System — DEVICE
    Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.

Study Details

A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System

Key Dates

Start date
Jan 23, 2019
Status verified
Jun 2024
Primary completion
Jan 31, 2035
Completion
Jul 31, 2035

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Prospective Subjects
    Enrolled in the study pre-surgery. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
  • Arm: Retrospective to Prospective
    Subjects enrolled in the study post- surgery then continue to participate in the study prospectively. Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively).
  • Arm: Retrospective Only Subjects
    Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution.

Primary Outcome Measure

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR. [ Time Frame: Preoperative ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado HealthAuroraColorado80045
Frank Somoza
Michael Dayton, MD (PRINCIPAL_INVESTIGATOR)
Florida Research AssociatesDeLandFlorida32720
Diane Martin
Mark Hollmann, MD (PRINCIPAL_INVESTIGATOR)
Nevada Orthopaedic and Spine CenterLas VegasNevada89128
Ronald Hillock, MD
Ronald Hillock, MD (PRINCIPAL_INVESTIGATOR)
Crystal ClinicAkronOhio44333
Ginny Texter
Ian Gradisar, MD (PRINCIPAL_INVESTIGATOR)
Medical University South CarolinaCharlestonSouth Carolina29425
Lisa Mock
Richard Friedman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Health· Aurora, COFlorida Research Associates· DeLand, FLNevada Orthopaedic and Spine Center· Las Vegas, NVCrystal Clinic· Akron, OHMedical University South Carolina· Charleston, SC

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