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ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert (ATX)

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ClinicalTrials.gov Identifier: NCT02520544
Recruitment Status : Active, not recruiting
First Posted : August 13, 2015
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Stryker European Operations BV

Tracking Information
First Submitted Date  ICMJE June 11, 2015
First Posted Date  ICMJE August 13, 2015
Last Update Posted Date January 22, 2021
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
Survivorship of the device [ Time Frame: 10 years Follow-up ]
Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
  • Investigation of clinical performance and patient outcome with HHS (Harris Hip Score) patient questionnaire [ Time Frame: pre-operative, 1, 3, 5, 7 and 10 years follow-up ]
    Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
  • Investigation of clinical performance and patient outcome with Oxford Hip Score patient questionnaire [ Time Frame: pre-operative, 1, 3, 5, 7 and 10 years follow-up ]
    Outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement (THR) surgery. Grading 0 to 19 indicate severe hip arthritis, 40 to 48 indicate satisfactory joint function.
  • Investigation of clinical performance and patient outcome with EuroQuol-5 dimension patient questionnaire (EQ-5D ) [ Time Frame: pre-operative, 1, 3, 5, 7 and 10 years follow-up ]
    The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert
Official Title  ICMJE THE ATX REGISTRY ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert International Multicentre Surveillance Register
Brief Summary The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years.
Detailed Description This is a prospective international multicentre surveillance register. The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years. All institutions willing to participate to the register, able to recruit at least 20 patients (up to 100 patients)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthroplasty, Replacement, Hip
Intervention  ICMJE
  • Device: Accolade stem
    Total hip replacement
  • Device: Accolade II stem
    Total hip replacement
  • Device: Trident/Tritanium cup
    Total hip replacement
Study Arms  ICMJE
  • Active Comparator: Accolade stem
    All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner.
    Interventions:
    • Device: Accolade stem
    • Device: Trident/Tritanium cup
  • Active Comparator: Accolade II stem
    All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner.
    Interventions:
    • Device: Accolade II stem
    • Device: Trident/Tritanium cup
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 7, 2015)
497
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and non-pregnant female patients between 18-75 years of age.
  2. Patients requiring uncemented primary THA (Total Hip Arthroplasty), suitable for the use of the Accolade stem and Trident/Tritanium cup.
  3. Patients with a diagnosis of osteoarthritis (OA).
  4. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation.
  5. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion Criteria:

  1. Patients who require revision of a previously implanted hip prosthesis.
  2. Patients who had a THA on contralateral side within the last 6 months.
  3. Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome was considered unsatisfactory or not good (Harris Hip Score < 85).
  4. Patients who will need lower limb joint replacement for another joint within one year.
  5. Patients requiring bilateral hip replacement.
  6. Patients who have had a prior procedure of acetabular osteotomy.
  7. Patients with acute femoral fractures
  8. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI 35).
  9. Patients with active or suspected infection.
  10. Patients with malignancy - active malignancy.
  11. Patients with severe osteoporosis, rheumatoid arthritis (RA), Paget's disease or renal osteodystrophy.
  12. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
  13. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
  14. Female patients planning a pregnancy during the course of the study.
  15. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
  16. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
  17. Patients with other severe concurrent joint involvements, which can affect their outcome.
  18. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
  19. Patient with a known sensitivity to device materials.
  20. Patients under the protection of law (e.g. guardianship).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02520544
Other Study ID Numbers  ICMJE H-S-038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stryker European Operations BV
Study Sponsor  ICMJE Stryker European Operations BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Bolder, MD Amphia Zieknhuis Breda
PRS Account Stryker European Operations BV
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP