By InvitationNot Applicable

Exactech Knee Systems Post Market Clinical Follow-up

United States1,879 participantsStarted 2023-12-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Cohort 1. Prospective / Subjects Enrolled in the study pre-surgery: Subjects who agree to participate in the study have not had surgery prior to being enrolled in the study. Skeletally mature (18 years of age or older). The subject is willing and able to provide written informed consent for participation in the study. Subject is to receive an Exactech Knee System TKA for any approved indication for use. The knee replacement will be performed by the investigator or a sub- investigator. The devices will be used according to the approved indications. Cohort 2. Retrospective to Prospective Subjects enrolled in the study post- surgery then continue to participate in the study prospectively. Subjects who agree to participate, who have had surgery prior to enrollment in the study. Data for these subjects will be collected from the subject's medical record for the time-period prior to enrollment in the study containing data pertaining to the preoperative time period and index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time-period (prospectively). Skeletally mature (18 years of age or older). The subject is willing and able to provide written informed consent for participation in the study. Subject received an Exactech Knee System TKA for any approved indication for use. The knee replacement was performed by the investigator or a surgeon sub-investigator. The devices are/were used according to the app…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Objective

Timeframe: 10 Years

Trial details

NCT IDNCT07107581

SponsorExactech

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2035-12

View on ClinicalTrials.gov More Knee Arthroplasty, Total trials