Optetrak Knee System Post Market Clinical Follow-Up

Active, not recruiting

• Conditions: Knee Arthroplasty, Total

• Registration Number: NCT05788757
• Lead Sponsor: Exactech

Brief Summary

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

• Study Start: 2011-06-01
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2033-12-31
• Study Completion: 2034-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4588

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Society Score	annually through study completion, maximum of 10-years	(KSS) - validated outcome score
Hospital for Special Surgery Knee Score	annually through study completion, maximum of 10-years	(HSS) - validated outcome score
Oxford Knee Score	annually through study completion, maximum of 10-years	(OKS) - validated outcome score

Trial Locations

Locations (3)

Fallon Clinic; 🇺🇸 Worcester, Massachusetts, United States

Nevada Orthopaedic and Spine Center; 🇺🇸 Las Vegas, Nevada, United States

Medical University South Carolina; 🇺🇸 Charleston, South Carolina, United States