Actis Total Hip System 2 Year Follow-up (NCT02783274) | Clinical Trial Compass
CompletedNot Applicable
Actis Total Hip System 2 Year Follow-up
United States266 participantsStarted 2016-07-01
Plain-language summary
Two-year (2 year) information regarding the performance of the commercially available Actisâ„¢ 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. A severely painful and/or disable joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
✓. Avascular necrosis of the femoral head.
✓. Acute traumatic fracture of the femoral head or neck.
✓. Certain cases of ankylosis.
✓. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
✓. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
✓. Avascular necrosis of the femoral head.
✓. Non-union of femoral neck fractures.
Exclusion criteria
✕. Active local or systemic infection.
✕. Loss of musculature, neuromuscular compromise or vascular
✕. 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).
✕. Charcot's or Paget's disease.
✕. For hemi-hip arthroplasty, any pathological condition of the acetabulum, such as distorted acetabuli with irregularities, protrusion acetabuli (arthrokatadysis), or migrating acetabuli, that would preclude the use of the natural acetabulum as an appropriate articular surface for the hemi-hip prosthesis.
What they're measuring
1
Harris Hip Score- THA Subjects Per Protocol at 2 Years
Timeframe: 2 Years
2
Harris Hip Score- HHA Subjects Per Protocol at 2 Years
✕. The Subject is a woman who is pregnant or lactating.
✕. Existing contralateral hip that was implanted less than 6 months from the date of surgery at the time of consent into this study.
✕. Subjects requiring a simultaneous bilateral hip at the time of consent will be excluded; there can be only one Actis™ study hip. This also means that even if another hip system is used for the contralateral hip during simultaneous THAs, the Subject will be excluded. As noted above, Subjects who have an existing contralateral total hip replacement greater than 6 months postoperatively at the time of consent may be entered into this study if they qualify based upon the eligibility criteria and the approved labeling requirements.