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Trial record 1 of 1 for:    NCT02962362
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eGPS® in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02962362
Recruitment Status : Unknown
Verified November 2016 by Exactech.
Recruitment status was:  Recruiting
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Exactech

Brief Summary:
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.

Condition or disease
Osteoarthritis

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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: A Prospective Multi-center Data Collection to Assess the Exactech Guided Personalized Surgery eGPS® in Total Knee Arthroplasty
Study Start Date : August 2016
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement




Primary Outcome Measures :
  1. Hospital for Special Surgery knee score (HSS) [ Time Frame: 24 Months ]
    total score, pain, function

  2. Oxford Knee Score (OKS) [ Time Frame: 24 Months ]
    function, pain

  3. Knee Society Score (KSS) [ Time Frame: 24 Months ]
    total score, pain, function

  4. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 24 Months ]
    total score and subscales



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One hundred (100) subjects enrolled up to 4 sites. All subjects will be screened, enrolled and evaluated prospectively and be followed for up to two years. In the event a subject is enrolled and does not have surgery, additional patients may be screened and enrolled to reach the 100 subjects.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962362


Contacts
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Contact: Yassaman Najmabadi 352-377-1140 ext 4784 yassaman.najmabadi@exac.com

Locations
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United States, Florida
Exatech, Inc. Recruiting
Gainesville, Florida, United States, 32653
Contact: Yassaman Najmabadi    352-377-1140 ext 4784    yassaman.najmabadi@exac.com   
Principal Investigator: Michael P Bolognesi         
Principal Investigator: Quanjun Cui         
Principal Investigator: David Liu         
Sponsors and Collaborators
Exactech
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Responsible Party: Exactech
ClinicalTrials.gov Identifier: NCT02962362    
Other Study ID Numbers: CR15-001
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases