Exactech Knee Systems Post Market Clinical Follow-up

1. Sample Size and Justification

Enrollment targets are based on, but not limited to, a sample size of 1879 primary subjects. Subjects will be enrolled based on a statistical estimation of the sample size needed to examine the primary outcome of survivorship (i.e., implant revision). The below table describes the distribution of enrollment. Additional subjects and component types may be enrolled beyond those described below.

1. Truliant CR, n=308 Cemented Femoral, n=154 Porous Femoral, n=154 Tibial Insert CR, n=154 Tibial Insert CRC, n=154
2. Truliant PS, n=610 Cemented Femoral, n=305 Porous Femoral, n=305 Tibial Insert PS, n=305 Tibial Insert PSC, n=305
3. Logic CR, n=308 Cemented Femoral, n=154 Porous Femoral, n=154 Tibial Insert CR, n=154 Tibial Insert CRC, n=154
4. Logic PS, n=610 Cemented Femoral, n=305 Porous Femoral, n=305 Tibial Insert PS, n=305 Tibial Insert PSC, n=305
5. Constrained Condylar Components, n=43 CC Cemented Femoral Components, n=43 CC Tibial Inserts, n=43 Each product's subgroups share the same parameters and assumptions resulting in equal sample size. Sample sizes are estimated by component to ensure sufficient clinical data on each Total Knee Arthroplasty (TKA) component from each system. Because a patient must undergo a TKA with both a tibial insert and a femoral component, that individual patient will count toward the sample size for each component. All calculations consider an estimated 40% attrition rate. The sample size calculations indicate the estimated width of the 95% confidence limits for the primary endpoint, namely implant survivorship at 10 years, based on data obtained from the literature. The calculation generated a proposed sample size sufficient to support a 10-year survivorship analysis. To ensure data consistency and quality across the planned study time points, the sample size estimation is applied to the prospectively enrolled subjects only.
6. Data Collection Standard follow-up visits should be conducted to collect ongoing subject outcomes data. Electronic Patient Reported Outcomes (ePRO) may be available for subjects/sites to use for collection of safety data and patient reported outcomes.
7. Data Collection Forms/Logs Paper Case Report Forms (CRFs) will be provided to assist sites with data collection, if requested. The use of paper CRFs may be implemented into the site's workflow completely, partially, or not at all. All data submitted to Exactech through an eCRF within the EDC must be verifiable in the patient's medical records or paper CRF. The original source of data submitted via electronic case report forms (eCRFs) for this study must be established prior to data collection.
8. Data Recording: An electronic data capture (EDC) system will be used for recording data in this study. The EDC system provides an electronic version of the paper forms that allow for simple online completion and submission of the forms. The EDC system can be accessed from any computer with internet capabilities and provides a secure internet connection for data entry. Each site will need to be assigned login information (User ID and Password) from Exactech to access the forms. Sites will also be provided with the paper forms, if requested, so that all appropriate data can be collected during each subject visit. The data collected on the paper forms can then be used to complete the online (Internet) forms.
9. Data Quality Assurance Investigative sites will be notified of incomplete or discrepant data so that corrections or additional data can be provided, as appropriate. Whether a site is using paper or electronic forms it is important to fill out each form as completely, legibly, and accurately as possible before submitting it to the Sponsor via eCRF.
10. Outcome Assessment Analysis of clinical outcomes will be summarized using appropriate descriptive statistics (means, standard deviations, medians, minimum and maximums for continuous variables, and percentages for categorical variables at each point in time).
11. Device Survival A Kaplan-Meier survival curve analysis will be performed to account for variability in length of follow- up.
12. Complications Device-related complications, both "possibly," and "definitely" related, as well as serious adverse events will be summarized by reporting the total number of reported events by the number of operative cases.
13. Study Monitoring Study monitoring will occur according to the Monitoring Plan set out specific to this study. The monitoring duties are to aid the Clinical Investigator in the production and maintenance of complete, legible, well-organized, and easily retrievable data. In addition, the Monitor will be responsible for ensuring the Clinical Investigators' understanding of the CIP and all applicable regulations.
14. Good Clinical Practices (GCP) This investigation will be conducted in accordance with the principles of BS EN International Organization for Standardization (ISO) 14155:2020 titled "Clinical investigation of medical devices for human subjects" and International Council for Harmonisation (ICH) GCP (Good Clinical Practice) guidelines.