EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
NCT ID
NCT06631638
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
DePuy Orthopaedics
Conditions
Avascular Necrosis of the Femoral Head, Certain Cases of Ankylosis, Congential Hip Dysplasia, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Overview
ClinicalTrials.gov lists this study as Recruiting.
Official title: Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
Enrollment: 118 participants (Estimated).
What is being studied
Device: EMPHASYS Cup with VHN
Who may be eligible
Ages
21 Years to no maximum
Sex
All
Healthy volunteers accepted
No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
1. All hip replacement component devices are to be used according to the approved indications.
2. 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.
3. The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced
4. Individuals who are able to speak, read, and comprehend the Informed Participant Consent Document and willing and able to provide consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
5. Individuals who are willing and able to complete follow-up as specified by the study protocol.
6. 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.
7. Individuals who are not bedridden per the discretion of the investigator.
8. Individuals who are a minimum age of 21 years at the time of consent
Exclusion Criteria:
1. Active local or systemic infection.
2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
3. 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).
4. Charcot's or Paget's disease.
5. The Subject is a woman who is pregnant or lactating.
6. Subject had a contralateral amputation.
7. Previous partial hip replacement in affected hip.
8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
9. Contralateral hip was replaced less than 6 months prior to surgery date.
10. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
11. 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.
12. Subject has a medical condition with less than 2 years of life expectancy.
13. 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.
Study locations
2 study locations are listed.
Recruiting site status is explicitly provided for 2 locations; 2 are listed as Recruiting.
Countries: United States
Florida, United States: 1
North Carolina, United States: 1
Sample of listed locations
Florida Orthopaedic Institute — Gainesville, Florida, 32607, United States — Recruiting
Carolina Orthopaedic and Sports Medicine Center — Gastonia, North Carolina, 28054, United States — Recruiting
Trial information can change. Confirm current study details with the study team or the registry.
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