Actis Total Hip System 2 Year Follow-up
Part of paid clinical trials in Louisville, Kentucky.
- Sponsor
- DePuy Orthopaedics
- Study ID
- NCT02783274
- Status
- Completed
Conditions
- Acute Traumatic Fracture of the Femoral Head or Neck
- Avascular Necrosis of the Femoral Head
- Certain Cases of Ankylosis
- Certain High Sub-Capital & Femoral Neck Fractures in Elderly
- Congenital Hip Dysplasia
- Non-union of Femoral Neck Fractures
- Osteoarthritis
- Rheumatoid Arthritis
- Traumatic Arthritis
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Actis Total Hip System — DEVICETotal Hip Replacement and Hemi-hip Replacement
Study Details
Two-year (2 year) information regarding the performance of the commercially available Actis™ Total Hip System in order to obtain and evaluate the clinical outcomes on a series of cementless primary total hip arthroplasty (THA) and hemi-hip arthroplasty procedures using clinical, radiographic and device and procedure related adverse event assessments.
Key Dates
- Start date
- Jul 1, 2016
- Status verified
- Aug 2025
- Primary completion
- Mar 13, 2024
- Completion
- Mar 13, 2024
Study Design
- Enrollment
- 266 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Actis Total Hip SystemThe Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
Primary Outcome Measure
Harris Hip Score- THA Subjects Per Protocol at 2 Years [ Time Frame: 2 Years ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Louisville | Kentucky | 40241 | - |
| - | Boston | Massachusetts | - | - |
| - | Rochester | Minnesota | - | - |
| - | Lebanon | New Hampshire | - | - |
| - | New York | New York | - | - |
| - | Charlotte | North Carolina | - | - |
| - | Philadelphia | Pennsylvania | - | - |
| - | Austin | Texas | - | - |
| - | Renton | Washington | - | - |
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