Phase
Condition
Rheumatoid Arthritis
Osteoarthritis
Arthritis And Arthritic Pain
Treatment
EMPHASYS Cup with VHN
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All hip replacement component devices are to be used according to the approvedindications.
The subject is undergoing a standard of care primary uncemented hip replacement withthe EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral,anterolateral, or direct lateral approach with the subject in the lateral decubitusposition.
The subject is a candidate for implantation utilizing the VELYS Hip Navigationsystem with CUPTIMIZE advanced
Individuals who are able to speak, read, and comprehend the Informed ParticipantConsent Document and willing and able to provide consent for participation in thestudy and have authorized the transfer of his/her information to DePuy Synthes.
Individuals who are willing and able to complete follow-up as specified by the studyprotocol.
Individuals who are willing and able to complete the Subject Hip Outcomesquestionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the studyprotocol.
Individuals who are not bedridden per the discretion of the investigator.
Individuals who are a minimum age of 21 years at the time of consent
Exclusion
Exclusion Criteria:
Active local or systemic infection.
Loss of musculature, neuromuscular compromise or vascular deficiency in the affectedlimb rendering the procedure unjustified.
Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, therecould be considerable migration of the prosthesis or a significant chance offracture of the femoral shaft and/or the lack of adequate bone to support theimplant(s).
Charcot's or Paget's disease.
The Subject is a woman who is pregnant or lactating.
Subject had a contralateral amputation.
Previous partial hip replacement in affected hip.
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
Contralateral hip was replaced less than 6 months prior to surgery date.
Subject is currently involved in any personal injury litigation, medical-legal orworker's compensation claims.
Subject was diagnosed and is taking prescription medications to treat a musculardisorder that limits mobility due to severe stiffness and pain such as fibromyalgiaor polymyalgia.
Subject has a medical condition with less than 2 years of life expectancy.
Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has apsychological disorder that could affect their ability to complete subject reportedquestionnaires or be compliant with follow-up requirements.
Study Design
Connect with a study center
UC Davis Health System
Sacramento, California 95817
United StatesSite Not Available
UC Davis Health System
Sacramento 5389489, California 5332921 95817
United StatesSite Not Available
Florida Orthopaedic Institute
Gainesville, Florida 32607
United StatesActive - Recruiting
Florida Orthopaedic Institute
Gainesville 4156404, Florida 4155751 32607
United StatesSite Not Available
Northwell Health
Lake Success, New York 11042
United StatesSite Not Available
Montefiore Medical Center
The Bronx, New York 10461
United StatesSite Not Available
Northwell Health
Lake Success 5123853, New York 5128638 11042
United StatesSite Not Available
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10461
United StatesSite Not Available
CaroMont Hospital
Gastonia, North Carolina 28054
United StatesSite Not Available
Carolina Orthopaedic and Sports Medicine Center
Gastonia, North Carolina 28054
United StatesActive - Recruiting
Carolina Orthopaedic and Sports Medicine Center
Gastonia 4467732, North Carolina 4482348 28054
United StatesSite Not Available

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