Optetrak Knee System Post Market Clinical Follow-Up

A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System

A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Device: Optetrak Total Knee System

Detailed Description

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 a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).

• Study Type: Observational
• Enrollment (Estimated): 4588

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01608
      • Fallon Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Nevada Orthopaedic and Spine Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients must qualify for surgery per indications and contraindications as well as meet all the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the discretion of the surgeon.

Description

Inclusion Criteria:

• Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
• Patient is skeletally mature
• Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary

Exclusion Criteria:

• Patient has a local or systemic infection
• Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
• Patient is pregnant
• Patient has a mental or physical condition that may invalidate evaluation of the data - ---
• Patient is a prisoner
• Surgery is contraindicated according to the applicable product package insert

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enrolled Subjects; Patients recruited from the population undergoing knee arthroplasty as part of standard of care. Patients who meet all the inclusion criteria and none of the exclusion criteria should be presented with an opportunity to undergo the informed consent process.	Device: Optetrak Total Knee System; Total Knee Arthroplasty using Exactech's Optetrak branded components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score	(KSS) - validated outcome score	Preoperative
Knee Society Score	(KSS) - validated outcome score	6 month postoperative
Knee Society Score	(KSS) - validated outcome score	annually through study completion, maximum of 10-years
Hospital for Special Surgery Knee Score	(HSS) - validated outcome score	Preoperative
Hospital for Special Surgery Knee Score	(HSS) - validated outcome score	6 month postoperative
Hospital for Special Surgery Knee Score	(HSS) - validated outcome score	annually through study completion, maximum of 10-years
Oxford Knee Score	(OKS) - validated outcome score	Preoperative
Oxford Knee Score	(OKS) - validated outcome score	6 month postoperative
Oxford Knee Score	(OKS) - validated outcome score	annually through study completion, maximum of 10-years

Collaborators and Investigators

• Sponsor: Exactech

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): June 1, 2034

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CR05-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes