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

THE ATX REGISTRY ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert International Multicentre Surveillance Register

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Accolade stem; Device: Trident/Tritanium cup; Device: Accolade II stem

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: Interventional
• Enrollment (Actual): 472
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Ziekenhuis Netwerk Antwerpen
• Netherlands
  • Breda, Netherlands
    • Amphia Ziekenhuis
  • Rotterdam, Netherlands
    • Maatschap Orthopaedie Ikazia
  • Sittard, Netherlands
    • Orbis Medisch Concern
  • Zevenaar, Netherlands
    • Rijnstate Arnhem
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands
      • St. Antonius Ziekenhuis
• Sweden
  • Hässleholm, Sweden
    • Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
• United Kingdom
  • Harrogate, United Kingdom
    • Harrogate and District NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and non-pregnant female patients between 18-75 years of age.
2. Patients requiring uncemented primary Total Hip Arthroplasty (THA), 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Trident/Tritanium cup; Total hip replacement; Device: Accolade II stem; Total hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship of the Device	Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).	10 years Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire	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	pre-operative, 1, 3, 5, 7 and 10 years follow-up
Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire	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, each scored from 0-4 (worst to best), giving a final score with a total range of 0-48. A final score of 0 to 19 indicates severe hip arthritis, 20-29 indicates moderate to severe symptoms, 30-39 indicates mild to moderate symptoms, and 40 to 48 indicates satisfactory joint function.	pre-operative, 1, 3, 5, 7 and 10 years follow-up
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire	The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and the EQ-5D descriptive system, time trade-off (TTO). The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The TTO index values on a scale between -1(low) and 1(high) show the average health status according to the 5 dimensions. A low score shows worse health, and a high score shows better health.	pre-operative, 1, 3, 5, 7 and 10 years follow-up

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Stefan Bolder, MD, Amphia Zieknhuis Breda

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: August 7, 2015
• First Posted (Estimated): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: H-S-038