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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 9, 2019
Sponsor:
Information provided by (Responsible Party):
Stryker European Operations BV

Brief Summary:
The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Device: Accolade stem Device: Accolade II stem Device: Trident/Tritanium cup Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 497 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: THE ATX REGISTRY ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert International Multicentre Surveillance Register
Study Start Date : January 2012
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
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.
Device: Accolade stem
Total hip replacement

Device: Trident/Tritanium cup
Total hip replacement

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.
Device: Accolade II stem
Total hip replacement

Device: Trident/Tritanium cup
Total hip replacement




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT02520544


Locations
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Belgium
Ziekenhuis Netwerk Antwerpen
Antwerpen, Belgium
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Maatschap Orthopaedie Ikazia
Rotterdam, Netherlands
Orbis Medisch Concern
Sittard, Netherlands
Rijnstate Arnhem
Zevenaar, Netherlands
Sweden
Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
Hässleholm, Sweden
United Kingdom
Harrogate and District NHS Foundation Trust
Harrogate, United Kingdom
Sponsors and Collaborators
Stryker European Operations BV
Investigators
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Principal Investigator: Stefan Bolder, MD Amphia Zieknhuis Breda

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Responsible Party: Stryker European Operations BV
ClinicalTrials.gov Identifier: NCT02520544     History of Changes
Other Study ID Numbers: H-S-038
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019