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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02962362

Enrollment

Registered

2016-11-11

Start date

2016-08-31

Completion date

2021-11-30

Last updated

2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results