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Enrolling by invitation Observational

Exactech Knee Systems Post Market Clinical Follow-up

NCT07107581 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Observational
Started
2023-12-01
Last updated
2025-08-06

Condition(s) studied

Knee Arthroplasty, TotalPartial Knee Replacement

Investigational drug(s) / intervention(s)

Prospective / Subjects Knee ArthroplastyRetrospective to ProspectiveRetrospective Only Subjects

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 approved indications. Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre- operative, operative, and applicable postoperative data available in the subject's medical records, related to the Exactech Knee System prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission: Pre-Operative: Demographic Data Gender Age at surgery Height/Weight Indication for surgery Prior Injuries/Surgeries on index knee Comorbidities Operative: Date of Surgery Type of Surgery (Primary / Revision) All component product information, including catalogue reference numbers. Adverse Event Information, if applicable Cohort 3. Retrospective Only Subjects Enrolled in the study post-study surgery with no intent to continue as prospective subjects. Note: No prospective data may be collected from a subject if they are enrolled under this cohort unless the subject is willing and able to provide written informed consent for participation in the study, in which case they should be part of Cohort 2. Skeletally mature at the time of the surgery (18 years of age or older). The patient's clinical record includes a signed waiver that clearly expresses patient consent for the use of available clinical data for the purpose of clinical research outside of the operating institution. The patient's clinical record includes a documented procedure that includes, or is related to, TKA with an Exactech Knee System device. The knee replacement was performed by the investigator or a surgeon sub-investigator. The devices are/were used according to the approved indications. Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria and have a minimum of the following pre- operative, operative, and applicable postoperative data available in the subject's medical records, related to the Exactech Knee System prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for submission: Pre-Operative: Demographic Data Gender Age at surgery Height/Weight Indication for surgery Prior Injuries/Surgeries on index knee Comorbidities Operative: Date of Surgery Type of Surgery (Primary / Revision) All component product information, including catalogue reference numbers. Adverse Event Information, if applicable Exclusion Criteria: Patient was \<18 years of age at time of surgery Patient does not meet indicated population for use criteria for this device. Patient is pregnant Patient is a prisoner Patient has a physical or mental condition that would invalidate the results Patient is contraindicated for the surgery (e.g., metal allergy) \-

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)

FacilityCityRegionStatus
Florida Orthopaedic Associates DeLand Florida
Official registry record

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