Clinical trial NCT06631638: EMPHASYS Cup Position in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Official title: Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Traumatic Arthritis
Rheumatoid Arthritis
Congential Hip Dysplasia
Avascular Necrosis of the Femoral Head
Certain Cases of Ankylosis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 118
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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 (and CUPTIMIZE pre-operative planning tool within the VELYS system).
4. 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.
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.

Primary outcomes:
measure: Inclination Success
timeFrame: 6 weeks
measure: Anteversion Success
timeFrame: 6 weeks
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 12 weeks
measure: Radiographic Outcomes
timeFrame: 12 weeks
measure: EQ-5D-5L
timeFrame: 12 weeks
measure: Forgotten Joint Score
timeFrame: 6 weeks
measure: Operating Room Times
timeFrame: Immediately after the Surgical Procedure
measure: Leg Length Discrepancy
timeFrame: Immediately after the Surgical Procedure
measure: Complication Rates
timeFrame: 30 days
measure: Complication Rates
timeFrame: 90 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
city: Gainesville
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Gastonia
country: United States
facility: CaroMont Hospital
state: North Carolina
Study officials:
References: