Exactech Knee Systems Post Market Clinical Follow-up

Part of paid clinical trials in DeLand, Florida.

Sponsor
Exactech
Study ID
NCT07107581
Status
Enrolling By Invitation

Conditions

  • Knee Arthroplasty, Total
  • Partial Knee Replacement

Eligibility Criteria

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

Interventions

  • Prospective / Subjects Knee Arthroplasty — DEVICE
    Knee Arthroplasty
  • Retrospective to Prospective — DEVICE
    Knee Arthroplasty
  • Retrospective Only Subjects — DEVICE
    Knee Arthroplasty

Study Details

This is a multi-center, open-label, prospective and retrospective clinical outcomes study. Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive an Exactech Knee System total knee arthroplasty (TKA) prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Subjects will, or will have already, undergo/undergone TKA as prescribed by the operating surgeon in a medical center with appropriate facilities and appropriately trained personnel. Treatment will be with the knee replacement components described in this protocol. The surgical procedure shall be conducted according to the appropriate Surgical Technique (Reference #: 712-35-41 and 712-35-35 as applicable) and product labeling for an Exactech Knee System and in accordance with the standard of care of the operating surgeon. The medical devices and procedures used in this study are considered standard of care and are not considered investigational or experimental. Information about the subject's preoperative conditions, demographics, previous surgical procedures, devices used, surgical procedure, postoperative outcomes, radiographic outcomes, and adverse events should be collected according to the Protocol Activity Schedule below: Cohort 1. Prospective Subjects Enrolled in the study pre-surgery: Cohort 2. Retrospective-to-Prospective Subjects - Subjects Enrolled in the study post-surgery. Cohort 3. Retrospective Only Subjects - Data collection for the Retrospective Only Subjects will occur through a retrospective, observational, medical chart review. Visit \& Windows of data to be collected for all Cohorts: * Preoperative Visit- Within ≤ 3 months prior to surgery * Surgery/Discharge -Day of Surgery /Day of Discharge * 6 Week Post-Op Visit - (Porous cohort only) -3 weeks - 7 weeks * 6 Month Post-Op Visit - (Required for porous, optional for cemented) - 8 weeks - 26 weeks * 1 through 10 Year Post-Operative Follow-Up Visits (As per the surgeon's standard of care) - ±6 months Clinical Outcomes to be collected (only if available for Cohort 3): * Functional Performance * Range of Motion 1\. Patient Outcomes to be collected (only if available for Cohort 3): * Knee injury and Osteoarthritis Outcome Score for Joint Replacement Jr. (KOOS Jr.) * Knee Society Score (KSS) / Hospital for Special Surgery Score (HSS) * Oxford Knee Score (OKS) * Visual Analog Scale (VAS) for Pain and Patient Satisfaction 2\. Safety Outcomes: a. Adverse Events * Procedure-related adverse events, * Device related adverse events, * Readmissions, and Revisions b. Radiographic Outcomes (Assessment) (e.g., radiolucent lines, subsidence) c. Survivorship Rates - Kaplan Meier Analysis with a survivorship distribution function

Key Dates

Start date
Dec 1, 2023
Status verified
Aug 2025
Primary completion
Dec 31, 2035
Completion
Jan 31, 2036

Study Design

Enrollment
1,879 participants (estimated)

Arms

  • Arm: Cohort 1. Prospective / Subjects Knee Arthroplasty
    Enrolled in the study pre-surgery
  • Arm: Cohort 2. Retrospective to Prospective
    Subjects enrolled in the study post- surgery then continue to participate in the study prospectively.
  • Arm: Cohort 3. Retrospective Only Subjects
    Enrolled in the study post-study surgery with no intent to continue as prospective subjects.

Primary Outcome Measure

Primary Objective [ Time Frame: 10 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Florida Orthopaedic AssociatesDeLandFlorida32720-

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Florida Orthopaedic Associates· DeLand, FL

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