Actis Total Hip System 2 Year Follow-up
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- 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
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single cohort of Total Hips and the protocol also includes a single cohort for Hemi-hips. No comparisons are made to comparator devices, no randomization (open label). gathering data for a Post-market clinical follow-up study.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
Description
A minimum of 10 study sites. A prospective, uncontrolled, non-randomized, multicenter study. A total of 255 Subjects to include a minimum of 225 Primary THA Subjects and a Sub-group with a minimum of 30 hemi-hip arthroplasty Subjects will be prospectively enrolled into the study. All Subjects will b...
A minimum of 10 study sites. A prospective, uncontrolled, non-randomized, multicenter study. A total of 255 Subjects to include a minimum of 225 Primary THA Subjects and a Sub-group with a minimum of 30 hemi-hip arthroplasty Subjects will be prospectively enrolled into the study. All Subjects will be seen for a preoperative clinic visit at the time of consent, and evaluated at the time of surgery, 6 weeks (28-70 days), 3 months (71-132 days), minimum 1 year (304-668 days), and minimum 2 years (669-1,763 days) postoperatively.
Tracking Information
- NCT #
- NCT02783274
- Collaborators
- Not Provided
- Investigators
- Study Director: Deborah German, BS DePuy Synthes
Get Well Soon