Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis Clinical Trial
Official title:
Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique
| Verified date | February 2022 |
| Source | DePuy Orthopaedics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.
| Status | Completed |
| Enrollment | 183 |
| Est. completion date | December 14, 2021 |
| Est. primary completion date | May 19, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | Inclusion Criteria: 1. All devices are to be used according to the approved indications 2. The patient is undergoing a standard of care hip replacement with the Pinnacle cup and a Corail, Summit, or Actis stem via the posterolateral, anterolateral, or direct lateral approach with the patient in the lateral decubitus position. 3. Individuals who are able to speak, read, and comprehend the Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes. 4. Individuals who are willing and able to complete follow-up as specified by the study protocol. 5. 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. 6. Individuals who are not bedridden. 7. 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 patient reported questionnaires or be compliant with follow-up requirements. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Istituto Orthopedico Galeazzi IRCCS | Milan | |
| Netherlands | Bravis Hospital | Bergen op Zoom | |
| Netherlands | Maastricht University Medical Center | Maastricht | |
| Netherlands | Canisius Wilhelmina Hospital | Nijmegen | |
| United Kingdom | Woodend Hospital | Aberdeen | Scotland |
| United Kingdom | Glan Clwyd Hospital | Rhyl | Wales |
| United States | Lowcountry Orthopaedics & Sports Medicine | Charleston | South Carolina |
| United States | Carolina Orthopaedic and Sports Medicine Center | Gastonia | North Carolina |
| United States | Orthopaedic Associates of Michigan | Grand Rapids | Michigan |
| United States | Mount Sinai Hospital | New York | New York |
| United States | Orthopedic Specialists and Sports Medicine | Newark | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| DePuy Orthopaedics |
United States, Italy, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite success of cup inclination and cup version. | The primary endpoint is acetabular cup position success at 6 weeks postoperatively. It is a composite endpoint; in order 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 Version Success: within 10 degrees of the planned version |
6 weeks | |
| Secondary | Inclination success | Inclination Success: within 10 degrees of the planned inclination | 6 weeks | |
| Secondary | Version success | Version success: within 10 degrees of the planned version | 6 weeks | |
| Secondary | 90 day postoperative complication rates | The number of subjects and the percentage of subjects with complications at 90 days post-operatively | 90 days postoperative | |
| Secondary | Harris Hip Score | Change from preoperative baseline for the Harris Hip Score | Baseline and 6 and 12 weeks postoperative | |
| Secondary | Forgotten Joint Score | Change from 6 week baseline for the Forgotten Joint Score | 6 and 12 weeks postoperative | |
| Secondary | EQ-5D-5L dimension score | Mean change from baseline for the specified time points | Baseline and 6 and 12 weeks postoperative | |
| Secondary | EQ-VAS score (subscore of EQ-5D-5L) | Mean change from baseline for the specified time points | Baseline and 6 and 12 weeks postoperative | |
| Secondary | EQ-5D-5L index value (if applicable) | Mean change from baseline for the specified time points | Baseline and 6 and 12 weeks postoperative | |
| Secondary | Radiographic Outcomes | Radiographs will be read by an independent radiographic reviewer (IRR) at 6 weeks to act as a baseline measurement to be compared to radiographs taken at later time points (12 weeks). Parameters measured include subsidence, migration, inclination and version angles, osteolysis, and radiolucency. | Baseline and 6 and 12 weeks postoperative |