Study to Assess Exactech's Guided Personalized Surgery eGPS® in Total Knee Arthroplasty

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT02962362
• Lead Sponsor: Exactech

Brief Summary

Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).

Detailed Description

The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Primary Completion: 2019-07
• Study Completion: 2021-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Patient requires a primary Optetrak Logic Total Knee Arthroplasty
• Patient is skeletally mature with no obvious mechanical defect
• Patient is mentally capable of completing follow-up visits
• Patient is 18 years of age or greater at time of surgery
• Patient will be available for follow-up out to 2 years
• Patient has consented to participate in the clinical study

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score (OKS)	24 Months	function, pain
Knee injury and Osteoarthritis Outcome Score (KOOS)	24 Months	total score and subscales
Hospital for Special Surgery knee score (HSS)	24 Months	total score, pain, function
Knee Society Score (KSS)	24 Months	total score, pain, function

Trial Locations

Locations (1)

Exatech, Inc.; 🇺🇸 Gainesville, Florida, United States