Actis Total Hip System 2 Year Follow-up — Actis14014  

Rheumatoid Arthritis Clinical Trial

Official title: Actis Total Hip System 2 Year Follow-up

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02783274
• Study type: Interventional
• Source: DePuy Orthopaedics
• Contact: Kirstin Cosgrove, BS
• Phone: 714-420-4589
• Email: KCosgro1@its.jnj.com
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2016
• Completion date: July 1, 2024