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

Osteoarthritis Clinical Trial

Official title:

A Prospective Multi-center Data Collection to Assess the Exactech Guided Personalized Surgery eGPS® in Total Knee Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02962362
• Other study ID #: CR15-001
• Status: Terminated
• Start date: August 2016
• Est. completion date: November 2021

Study information

• Verified date: August 2022
• Source: Exactech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: November 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	Exatech, Inc.	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital for Special Surgery knee score (HSS)	total score, pain, function	24 Months
Primary	Oxford Knee Score (OKS)	function, pain	24 Months
Primary	Knee Society Score (KSS)	total score, pain, function	24 Months
Primary	Knee injury and Osteoarthritis Outcome Score (KOOS)	total score and subscales	24 Months