Clinical Trial: Actis Total Hip System 2 Year Follow-up
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Actis Total Hip System 2 Year Follow-up
Brief 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 Summary:
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.
Sponsor: DePuy Orthopaedics
Current Primary Outcome: Primary endpoint - Harris Hip Score [ Time Frame: 2 Years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Harris Hip Score [ Time Frame: 3 Months & 1 Year ]This analysis will be conducted on THA subjects and hemi-arthroplasty subjects separately.
- Radiographic Outcomes [ Time Frame: 2 Years ]Radiographs will be read by an independent radiographic (IRR) reviewer at 6 weeks to act as a baseline measurement to be compared to radiographs taken at 2 years. Parameters measured include stem subsidence, shell migration, shell inclination angle, osteolytic lesions, radiolucencies, heterotopic ossification, demarcation lines (sclerotic lines), porous coating integrity (delamination/bead shedding), calcar remodeling, femoral stem tilt (appearance), and leg length discrepancy. This analysis will be conducted on THA subjects and Hemi-arthroplasty subjects separately.
- Adverse Events [ Time Frame: All intervals = Operative and 2 years ]Frequencies of AE's seriousness, severity, whether unanticipated will also be presented. This analysis will be conducted on THA subjects and hemi-arthroplasty subjects separately.
- Device Survivorship [ Time Frame: 2 Years ]Kaplan-Meier survivorship will be conducted with removal of any component, defined as revision, for any reason specifying the event of interest. This analysis will be conducted on THA subjects; hemi-arthroplasty subjects will be excluded.
- Stem Revision [ Time Frame: 2 Years ]Kaplan-Meier survivorship will be conducted with removal specifically of the femoral component, defined as revision. This analysis will be conducted on THA subjects; hemi-arthroplasty subjects will be excluded.
Original Secondary Outcome: Same as current
Information By: DePuy Orthopaedics
Dates:
Date Received: May 23, 2016
Date Started: July 2016
Date Completion: May 1, 2020
Last Updated: May 22, 2017
Last Verified: May 2017