Actis Total Hip System 2 Year Follow-up

Last updated: May 20, 2025
Sponsor: DePuy Orthopaedics
Overall Status: Completed

Phase

N/A

Condition

Arthritis And Arthritic Pain

Joint Injuries

Osteoarthritis

Treatment

Actis Total Hip System

Clinical Study ID

NCT02783274
14014
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Total primary hip replacement is indicated in the following conditions:

  1. A severely painful and/or disable joint from osteoarthritis, traumatic arthritis,rheumatoid arthritis, or congenital hip dysplasia.

  2. Avascular necrosis of the femoral head.

  3. Acute traumatic fracture of the femoral head or neck.

  4. Certain cases of ankylosis. Hemi-hip arthroplasty is indicated in the following conditions:

  5. Acute fracture of the femoral head or neck that cannot be appropriately reduced andtreated with internal fixation.

  6. Fracture dislocation of the hip that cannot be appropriately reduced and treatedwith internal fixation.

  7. Avascular necrosis of the femoral head.

  8. Non-union of femoral neck fractures.

  9. Certain high sub-capital and femoral neck fractures in the elderly.

  10. Degenerative arthritis involving only the femoral head in which the acetabulum doesnot require replacement.

  11. Pathology involving only the femoral head in which the acetabulum does not requirereplacement. Further inclusion criteria for individuals who, in the opinion of the PrincipalInvestigator, are suitable candidates for using the devices specified in thisprotocol and they are as follows:

  12. Individuals who are able to speak, read, and comprehend the informed patient consent (IPC) document and willing and able to provide informed patient consent forparticipation in the study and have authorized the transfer of his/her informationto DePuy Synthes (Joint Reconstruction).

  13. Individuals who are willing and able to return for follow-up as specified by thestudy protocol.

  14. Individuals who are a minimum age of 21 years at the time of consent.

  15. Individuals who are not bedridden.

  16. Individuals who are willing and able to complete the Subject Hip Outcomesquestionnaires (i.e., FJS-12, HOOS and Hip Evaluation) as specified by the studyprotocol.

  17. Individuals interested in participating in the parallel and optional PatientActivity Tracking portion of the study are required to link the Patient ActivityTracking device to their own well-functioning smartphone (i.e., iPhone or Androidphone) via a downloaded mobile application (i.e., ActiTrak™). If a Subject does nothave a smartphone, and would like to participate in the Patient Activity Trackingportion of the study, the Sponsor will be able to provide an Android type tablet towhich the required app can be downloaded.

  18. Individuals interested in participating in the optional Patient Activity Tracking (ActiTrak™) portion of the study must be willing to wear the Patient ActivityTracking device from the time of consent preoperative (if possible, based on date ofconsent) and for 3 months postoperative.

  19. Individuals interested in participating in the optional Patient Activity Tracking (ActiTrak™) portion of the study must have the ability to return at the 3 monthfollow-up visit in order to return the Patient Activity Tracking device, and ifapplicable, the Sponsor's Android tablet back to the study site.

Exclusion

Exclusion Criteria:

  • Subjects will be excluded if in the opinion of the Investigator, the individualmeets any of the following exclusions:
  1. Active local or systemic infection.

  2. Loss of musculature, neuromuscular compromise or vascular

  3. Poor bone quality, such as osteoporosis, where in the surgeon's opinion, therecould be considerable migration of the prosthesis or a significant chance offracture of the femoral shaft and/or the lack of adequate bone to support theimplant(s).

  4. Charcot's or Paget's disease.

  5. For hemi-hip arthroplasty, any pathological condition of the acetabulum, suchas distorted acetabuli with irregularities, protrusion acetabuli (arthrokatadysis), or migrating acetabuli, that would preclude the use of thenatural acetabulum as an appropriate articular surface for the hemi-hipprosthesis.

  6. The Subject is a woman who is pregnant or lactating.

  7. Existing contralateral hip that was implanted less than 6 months from the dateof surgery at the time of consent into this study.

  8. Subjects requiring a simultaneous bilateral hip at the time of consent will beexcluded; there can be only one Actis™ study hip. This also means that even ifanother hip system is used for the contralateral hip during simultaneous THAs,the Subject will be excluded. As noted above, Subjects who have an existingcontralateral total hip replacement greater than 6 months postoperatively atthe time of consent may be entered into this study if they qualify based uponthe eligibility criteria and the approved labeling requirements.

  9. Subject had a contralateral amputation.

  10. Subject has participated in a clinical investigation with an investigationalproduct (drug or device) in the last three months.

  11. Subject is currently involved in any personal injury litigation, medical-legalor worker's compensation claims.

  12. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or hasa psychological disorder that could affect their ability to complete patientreported questionnaires or be compliant with follow-up requirements.

  13. Subject was diagnosed and is taking prescription medications to treat amuscular disorder that limits mobility due to severe stiffness and pain such asfibromyalgia or polymyalgia.

  14. Subject has a medical condition with less than 2 years of life expectancy.Note: Diabetes, at present, has not been established as a contraindication.However, because of the increased risk for complications such as infection,slow wound healing, etc., the physician should carefully consider theadvisability of hip replacement in the severely diabetic patient.

Study Design

Total Participants: 266
Treatment Group(s): 1
Primary Treatment: Actis Total Hip System
Phase:
Study Start date:
July 01, 2016
Estimated Completion Date:
March 13, 2024

Study 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.

Connect with a study center

  • Louisville, Kentucky 40241
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Rochester, Minnesota
    United States

    Site Not Available

  • Lebanon, New Hampshire
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Charlotte, North Carolina
    United States

    Site Not Available

  • empty

    Winston Salem, North Carolina
    United States

    Site Not Available

  • empty

    Winston-Salem, North Carolina
    United States

    Site Not Available

  • Winston-Salem, North Carolina
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Renton, Washington
    United States

    Site Not Available

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