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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2021-11-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No