Exactech Knee Systems Post Market Clinical Follow-up

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

Conditions

• Knee Arthroplasty, Total
• Partial Knee Replacement

Interventions

DEVICE

Prospective / Subjects Knee Arthroplasty

Knee Arthroplasty

DEVICE

Retrospective to Prospective

Knee Arthroplasty

DEVICE

Retrospective Only Subjects

Knee Arthroplasty

Sponsors & Collaborators

• Exactech

  lead INDUSTRY

Principal Investigators

• Eric L Rohrs, PhD · Exactech

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2035-12-31

Completion

2036-01-31

FDA Device

Yes

Countries

• United States

Study Locations