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Actis Total Hip System 2 Year Follow-up (Actis14014)

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ClinicalTrials.gov Identifier: NCT02783274
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Actis Total Hip System 2 Year Follow-up
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
Active Comparator: 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 Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 3 Months & 1 Year ]
    This analysis will be conducted on THA subjects and hemi-arthroplasty subjects separately.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Total primary hip replacement is indicted 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 indicted in the following conditions:

  5. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
  6. Fracture dislocation of the hip that cannot be appropriately reduced and treated with 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 does not require replacement.
  11. Pathology involving only the femoral head in which the acetabulum does not require replacement.

    Further inclusion criteria for individuals who, in the opinion of the Principal Investigator, are suitable candidates for using the devices specified in this protocol 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 for participation in the study and have authorized the transfer of his/her information to DePuy Synthes (Joint Reconstruction).
  13. Individuals who are willing and able to return for follow-up as specified by the study 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 Outcomes questionnaires (i.e., FJS-12, HOOS and Hip Evaluation) as specified by the study protocol.
  17. Individuals interested in participating in the parallel and optional Patient Activity Tracking portion of the study are required to link the Patient Activity Tracking device to their own well-functioning smartphone (i.e., iPhone or Android phone) via a downloaded mobile application (i.e., ActiTrak™). If a Subject does not have a smartphone, and would like to participate in the Patient Activity Tracking portion of the study, the Sponsor will be able to provide an Android type tablet to which 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 Activity Tracking device from the time of consent preoperative (if possible, based on date of consent) 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 month follow-up visit in order to return the Patient Activity Tracking device, and if applicable, the Sponsor's Android tablet back to the study site.

Exclusion Criteria:

  • Subjects will be excluded if in the opinion of the Investigator, the individual meets 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, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
    4. Charcot's or Paget's disease.
    5. For hemi-hip arthroplasty, any pathological condition of the acetabulum, such as distorted acetabuli with irregularities, protrusion acetabuli (arthrokatadysis), or migrating acetabuli, that would preclude the use of the natural acetabulum as an appropriate articular surface for the hemi-hip prosthesis.
    6. The Subject is a woman who is pregnant or lactating.
    7. Existing contralateral hip that was implanted less than 6 months from the date of surgery at the time of consent into this study.
    8. Subjects requiring a simultaneous bilateral hip at the time of consent will be excluded; there can be only one Actis™ study hip. This also means that even if another hip system is used for the contralateral hip during simultaneous THAs, the Subject will be excluded. As noted above, Subjects who have an existing contralateral total hip replacement greater than 6 months postoperatively at the time of consent may be entered into this study if they qualify based upon the eligibility criteria and the approved labeling requirements.
    9. Subject had a contralateral amputation.
    10. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
    11. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
    12. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
    13. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia 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 the advisability of hip replacement in the severely diabetic patient.

Information from the National Library of Medicine

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


Contacts
Contact: Tammy L ODell, BS/CCRC/CCRA 574-372-7104 TODell2@its.jnj.com
Contact: Deborah German, BS 574-372-7421

Locations
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40241
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, Minnesota
Recruiting
Rochester, Minnesota, United States
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States
United States, New York
Recruiting
New York, New York, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
Withdrawn
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
United States, Texas
Recruiting
Austin, Texas, United States
United States, Washington
Active, not recruiting
Renton, Washington, United States
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Deborah German, BS DePuy Synthes

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT02783274     History of Changes
Other Study ID Numbers: 14014
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Sponsor to publish final study outcomes.
URL: http://

Additional relevant MeSH terms:
Osteonecrosis
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Fractures, Bone
Necrosis
Femoral Neck Fractures
Hip Dislocation
Hip Dislocation, Congenital
Femur Head Necrosis
Ankylosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Pathologic Processes
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Joint Dislocations
Bone Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities