NCT02783274

Actis Total Hip System 2 Year Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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 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.

Conditions

• Osteoarthritis
• Traumatic Arthritis
• Rheumatoid Arthritis
• Congenital Hip Dysplasia
• Avascular Necrosis of the Femoral Head
• Acute Traumatic Fracture of the Femoral Head or Neck
• Certain Cases of Ankylosis
• Non-union of Femoral Neck Fractures
• Certain High Sub-Capital & Femoral Neck Fractures in Elderly

Interventions

Type	Name	Description
DEVICE	Actis Total Hip System	Total Hip Replacement and Hemi-hip Replacement

Timeline

• Start date: 2016-07-01
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2016-05-26
• Last updated: 2025-08-15
• Results posted: 2025-05-22

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study