Actis Total Hip System 2 Year Follow-up (Actis14014)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02783274|
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : October 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Device: Actis Total Hip System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||255 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Actis Total Hip System 2 Year Follow-up|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||May 2, 2022|
|Estimated Study Completion Date :||May 2, 2022|
Actis Total Hip System
The Actis DuoFix Femoral Stem can be used for both a Total and Hemi-hip Replacement
Device: Actis Total Hip System
Total Hip Replacement and Hemi-hip Replacement
Other Name: Actis DuoFix Femoral Stem
- Primary endpoint - Harris Hip Score [ Time Frame: 2 Years ]Harris Hip Score at minimum 2 year postoperative. This analysis will be conducted on THA subjects and hemi-arthroplasty subjects separately.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783274
|Contact: Tammy L ODell, BS/CCRC/CCRA||574-372-7104||TODell2@its.jnj.com|
|Contact: Deborah German, BS||574-372-7421|
|United States, Kentucky|
|Louisville, Kentucky, United States, 40241|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States|
|United States, New Hampshire|
|Active, not recruiting|
|Lebanon, New Hampshire, United States|
|United States, New York|
|New York, New York, United States|
|United States, North Carolina|
|Charlotte, North Carolina, United States|
|Winston-Salem, North Carolina, United States|
|United States, Pennsylvania|
|Active, not recruiting|
|Philadelphia, Pennsylvania, United States|
|United States, Texas|
|Austin, Texas, United States|
|United States, Washington|
|Renton, Washington, United States|
|Study Director:||Deborah German, BS||DePuy Synthes|