Exactech, Inc.

Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol

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