Avascular Necrosis of the Femoral Head, Certain Cases of Ankylosis, Congential Hip Dysplasia, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
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.
Interventions
DEVICEEMPHASYS Cup with VHN
Total Hip Replacement with EMPHASYS Acetabular shell and Non-Invasive Navigation
Sponsors
DePuy Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint: Acetabular Cup Position Success at 6 Weeks | 6 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inclination Success | 6 weeks | Inclination Success: within 10 degrees of the planned inclination via the surgeon-defined preoperative plan. |
| Version Success | 6 weeks | Version Success: within 10 degrees of the planned version via the surgeon-defined preoperative plan. |
| Final Intraoperative Inclination | 12 weeks | Number of participants with final intraoperative inclination will be reported. |
| Final Intraoperative Version | 12 weeks | Number of participants with final intraoperative version will be reported. |
| Harris Hip Score | 12 weeks | 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. |
| Radiographic Outcomes | 12 weeks | 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. |
| EQ-5D-5L | 12 weeks | EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. |
| Forgotten Joint Score | 6 weeks | 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. |
| Operating Room Times | Immediately after the Surgical Procedure | Evaluate various operating room times such as anesthesia, fluoroscopy and surgical times. |
| Leg Length Discrepancy | Immediately after the Surgical Procedure | Leg Length discrepancy compared to surgeon target based on pre-operative planning |
| Complication Rates | 30 days | 30-day Complication Rate |
Countries
United States
Contacts
CONTACTSamantha Flamand
Outcome results
None listed