EMPHASYS Cup Position in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))

DePuy Synthes

Status

Begins enrollment this month

Conditions

Traumatic Arthritis

Osteoarthritis

Certain Cases of Ankylosis

Avascular Necrosis of the Femoral Head

Congential Hip Dysplasia

Rheumatoid Arthritis

Treatments

Device: EMPHASYS Cup with VHN

Study type

Interventional

Funder types

Industry

Identifiers

NCT06631638

DSJ202006

Details and patient eligibility

About

The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Hip-Spine Analysis software.

Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.

Enrollment

118 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All hip replacement component devices are to be used according to the approved indications.
The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position.
The subject is a candidate for implantation utilizing the VELYS Hip Navigation system (and CUPTIMIZE pre-operative planning tool within the VELYS system).
Individuals who are able to speak, read, and comprehend the Informed Consent Document and willing and able to provide informed subject consent for participation in the study 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 study protocol.
Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.
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 criteria

Active local or systemic infection.
Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(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 or worker's compensation claims.
Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or 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 a psychological disorder that could affect their ability to complete subject reported questionnaires or be compliant with follow-up requirements.