Optetrak Knee System Post Market Clinical Follow-Up

N/AActive Not RecruitingNCT05788757

Exactech4,588 enrolled

Overview

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

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

4,588

Conditions

Knee Arthroplasty, Total

Interventions

Optetrak Total Knee SystemDEVICE

Total Knee Arthroplasty using Exactech's Optetrak branded components.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Knee Society Score

(KSS) - validated outcome score

Time frame: Preoperative

Knee Society Score

(KSS) - validated outcome score

Time frame: 6 month postoperative

Knee Society Score

(KSS) - validated outcome score

Time frame: annually through study completion, maximum of 10-years

Hospital for Special Surgery Knee Score

(HSS) - validated outcome score

Time frame: Preoperative

Hospital for Special Surgery Knee Score

(HSS) - validated outcome score

Time frame: 6 month postoperative

Hospital for Special Surgery Knee Score

(HSS) - validated outcome score

Time frame: annually through study completion, maximum of 10-years

Oxford Knee Score

(OKS) - validated outcome score

Time frame: Preoperative

Oxford Knee Score

(OKS) - validated outcome score

Time frame: 6 month postoperative

Oxford Knee Score

(OKS) - validated outcome score

Time frame: annually through study completion, maximum of 10-years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.