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

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™ Advanced 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.
Brief Title
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Central Contacts
Central Contact Role
Contact
Central Contact Phone
610-241-3260
Central Contact Email
SFlamand@its.jnj.com
Completion Date
Completion Date Type
Estimated
Conditions
OSTEOARTHRITIS
TRAUMATIC ARTHRITIS
RHEUMATOID ARTHRITIS
CONGENTIAL HIP DYSPLASIA
AVASCULAR NECROSIS OF THE FEMORAL HEAD
CERTAIN CASES OF ANKYLOSIS
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.
Inclusion 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

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT06631638
Org Class
Industry
Org Full Name
DePuy Orthopaedics
Org Study Id
DSJ202006
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation
Primary Outcomes
Outcome Description
For an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks: Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan and version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
Outcome Measure
Composite endpoint: Acetabular Cup Position Success at 6 Weeks
Outcome Time Frame
6 Weeks
Secondary Outcomes
Outcome Description
Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan.
Outcome Time Frame
6 weeks
Outcome Measure
Inclination Success
Outcome Description
Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan.
Outcome Time Frame
6 weeks
Outcome Measure
Version Success
Outcome Description
Number of participants with final intraoperative inclination will be reported.
Outcome Time Frame
12 weeks
Outcome Measure
Final Intraoperative Inclination
Outcome Description
Number of participants with final intraoperative version will be reported.
Outcome Time Frame
12 weeks
Outcome Measure
Final Intraoperative Version
Outcome Description
Functional and health status as measured with the Harris Hip Score. This is a validated scoring system of the hip that has a result range of 0-100; the higher the score, the better the patient outcome.
Outcome Time Frame
12 weeks
Outcome Measure
Harris Hip Score
Outcome Description
High quality antero-posterior and lateral radiographs of the operative hip will be obtained during the same intervals as for the clinical evaluations. Views include the Standing AP Hip, Standing AP Pelvis, and Lateral (Modified Lauenstein) Hip. Preoperatively an additional three views will be taken including Lateral flex-seated, Lateral Standing and Standing AP Pelvis.
Outcome Time Frame
12 weeks
Outcome Measure
Radiographic Outcomes
Outcome Description
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Outcome Time Frame
12 weeks
Outcome Measure
EQ-5D-5L
Outcome Description
Functional and health status as measured with the Forgotten Joint Score (FJS-12). This is a validated score that assesses patient outcomes. The result range is 0-100 where a higher score mean a more favorable result.
Outcome Time Frame
6 weeks
Outcome Measure
Forgotten Joint Score
Outcome Description
Evaluate various operating room times such as anesthesia, fluoroscopy and surgical times.
Outcome Time Frame
Immediately after the Surgical Procedure
Outcome Measure
Operating Room Times
Outcome Description
Leg Length discrepancy compared to surgeon target based on pre-operative planning
Outcome Time Frame
Immediately after the Surgical Procedure
Outcome Measure
Leg Length Discrepancy
Outcome Description
30-day Complication Rate
Outcome Time Frame
30 days
Outcome Measure
Complication Rates
Outcome Description
90-day Complication Rate
Outcome Time Frame
90 days
Outcome Measure
Complication Rates
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Evan Schwechter
Investigator Email
eschwech@montefiore.org
Investigator Department
Orthopaedic Surgery
Study Department
Orthopaedic Surgery
Study Division
Orthopedic Surgery
Categories Mesh Debug
Arthritis --- OSTEOARTHRITIS
Arthritis --- ARTHRITIS
Orthopedics, Muscle & Bone --- ARTHRITIS
Orthopedics, Muscle & Bone --- JOINT DISEASES
Child Development & Autism --- MUSCULOSKELETAL DISEASES
Orthopedics, Muscle & Bone --- MUSCULOSKELETAL DISEASES
Orthopedics, Muscle & Bone --- RHEUMATIC DISEASES
Immune System --- IMMUNE SYSTEM DISEASES
Orthopedics, Muscle & Bone --- BONE DISEASES
MeSH Terms
OSTEOARTHRITIS
ARTHRITIS, RHEUMATOID
FEMUR HEAD NECROSIS
ARTHRITIS
JOINT DISEASES
MUSCULOSKELETAL DISEASES
RHEUMATIC DISEASES
CONNECTIVE TISSUE DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
AUTOIMMUNE DISEASES
IMMUNE SYSTEM DISEASES
OSTEONECROSIS
BONE DISEASES
NECROSIS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS