Exactech Knee Systems Post Market Clinical Follow-up
Condition(s) studied
Investigational drug(s) / intervention(s)
Prospective / Subjects Knee Arthroplasty: Knee Arthroplasty
Retrospective to Prospective: Knee Arthroplasty
Retrospective Only Subjects: Knee Arthroplasty
Study summary
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
Eligibility
Primary outcome measure(s)
- Primary Objective — 10 Years
The objective of this study is to assess the safety and performance of Exactech Knee System devices. Data will be collected to provide objective evidence of safety and performance of Exactech Knee Systems used in primary knee arthroplasty. Data may be analyzed to support future presentations and publications of an Exactech Knee System and may be used to provide clinical evidence of the post market outcomes of Exactech Knee Systems to regulatory authorities when required. The following data will be collected: Demographics (e.g., height, weight, age, and gender), Preoperative information (e.g., indication for surgery, comorbidities, pre-surgical assessments of knee function), Operative details (e.g., intra-operative findings, surgical approach, length of surgery), Product information (components used in the knee surgery), Adverse events (e.g., infection, device failure, revision), Implant survivorship, \& Patient Reported Outcomes (KOOS, KSS, HSS, OKS and/or VAS)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Florida Orthopaedic Associates | DeLand | Florida |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07107581 on ClinicalTrials.gov ↗ ← All trials in the USA