Exactech Knee Systems Post Market Clinical Follow-up

NCT07107581 | Enrolling By Invitation FDA Device

• 1 other identifier: TM- 2022-012696
• Study Type: observational
• Target: 1,879
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Exactech; Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  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)

  10 Years

Secondary Outcomes (1)

• Secondary Objective

  10 Years

Study Arms (3)

Cohort 1. Prospective / Subjects Knee Arthroplasty

Enrolled in the study pre-surgery

Device: Prospective / Subjects Knee Arthroplasty

Cohort 2. Retrospective to Prospective

Subjects enrolled in the study post- surgery then continue to participate in the study prospectively.

Device: Retrospective to Prospective

Cohort 3. Retrospective Only Subjects

Enrolled in the study post-study surgery with no intent to continue as prospective subjects.

Device: Retrospective Only Subjects

Interventions

Prospective / Subjects Knee Arthroplasty DEVICE

Knee Arthroplasty

Cohort 1. Prospective / Subjects Knee Arthroplasty

Retrospective to Prospective DEVICE

Knee Arthroplasty

Cohort 2. Retrospective to Prospective

Retrospective Only Subjects DEVICE

Knee Arthroplasty

Cohort 3. Retrospective Only Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subject received or is to receive an Exactech Knee System TKA for any approved indication for use.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exactech: lead

Study Sites (1)

Florida Orthopaedic Associates

DeLand, Florida, 32720, United States

Location

Related Publications (3)

• Martin A, Quah C, Syme G, Lammin K, Segaren N, Pickering S. Long term survivorship following Scorpio Total Knee Replacement. Knee. 2015 Jun;22(3):192-6. doi: 10.1016/j.knee.2015.01.007. Epub 2015 Mar 26.

  PMID: 25818502 BACKGROUND

• Scott CE, Clement ND, MacDonald DJ, Hamilton DF, Gaston P, Howie CR, Burnett R. Five-year survivorship and patient-reported outcome of the Triathlon single-radius total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1676-83. doi: 10.1007/s00167-014-2922-8. Epub 2014 Mar 13.

  PMID: 24623184 BACKGROUND

• Meftah M, White PB, Ranawat AS, Ranawat CS. Long-term results of total knee arthroplasty in young and active patients with posterior stabilized design. Knee. 2016 Mar;23(2):318-21. doi: 10.1016/j.knee.2015.10.008. Epub 2016 Jan 29.

  PMID: 26833096 BACKGROUND

MeSH Terms

Interventions

Longitudinal Studies

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric L Rohrs, PhD

  Exactech

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 6, 2025
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): January 1, 2036
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)