Arthroplasty, Replacement, HipATXNCT02520544
ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert
A study testing Accolade stem, Accolade II stem and Trident/Tritanium cup in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 8 sites in 4 countries.
Trial summary
The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Accolade stem, Accolade II stem and Trident/Tritanium cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jan 2012to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant female patients between 18-75 years of age.
- Patients requiring uncemented primary Total Hip Arthroplasty (THA), suitable for the use of the Accolade stem and Trident/Tritanium cup.
- Patients with a diagnosis of osteoarthritis (OA).
- 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.
- Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.
Who cannot join
- Patients who require revision of a previously implanted hip prosthesis.
- Patients who had a THA on contralateral side within the last 6 months.
- 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).
- Patients who will need lower limb joint replacement for another joint within one year.
- Patients requiring bilateral hip replacement.
- Patients who have had a prior procedure of acetabular osteotomy.
Show all 20Show fewer
- Patients with acute femoral fractures
- 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).
- Patients with active or suspected infection.
- Patients with malignancy - active malignancy.
- Patients with severe osteoporosis, rheumatoid arthritis (RA), Paget's disease or renal osteodystrophy.
- Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- 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.
- Female patients planning a pregnancy during the course of the study.
- Patients with systemic or metabolic disorders leading to progressive bone deterioration.
- 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.
- Patients with other severe concurrent joint involvements, which can affect their outcome.
- 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.
- Patient with a known sensitivity to device materials.
- Patients under the protection of law (e.g. guardianship).
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Netherlands5 sites
Amphia Ziekenhuis
Breda
St. Antonius Ziekenhuis
Nieuwegein, Utrecht
Maatschap Orthopaedie Ikazia
Rotterdam
Orbis Medisch Concern
Sittard
Rijnstate Arnhem
Zevenaar
Sweden1 site
Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
Hässleholm
United Kingdom1 site
Harrogate and District NHS Foundation Trust
Harrogate
About this study
Official title: 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.
Read the 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)
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Accolade stem, Accolade II stem, Trident/Tritanium cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accolade stemDevice
Total hip replacement
Accolade II stemDevice
Total hip replacement
Trident/Tritanium cupDevice
Total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| Accolade stem | Active comparator | 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. Receives: Device: Accolade stem; Device: Trident/Tritanium cup |
| Accolade II stem | Active comparator | 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. Receives: Device: Accolade II stem; Device: Trident/Tritanium cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of the Device
Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).
Measured: 10 years Follow-up
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: pre-operative, 1, 3, 5, 7 and 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2012
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Bolder, MD, Principal investigator, Amphia Zieknhuis Breda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520544
- Sponsor's protocol ID
- H-S-038
- Acronym
- ATX
- Status last verified
- Oct 2025
- First submitted
- 11 Jun 2015
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ATX REGISTRY ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert International Multicentre Surveillance Register
- ClinicalTrials.gov ID
- NCT02520544
- Acronym / sponsor ID
- ATX / H-S-038
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accolade stem | Active comparator | Device: Accolade stem, Device: Trident/Tritanium cupAll 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. |
| Accolade II stem | Active comparator | Device: Accolade II stem, Device: Trident/Tritanium cupAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and non-pregnant female patients between 18-75 years of age.
- Patients requiring uncemented primary Total Hip Arthroplasty (THA), suitable for the use of the Accolade stem and Trident/Tritanium cup.
- Patients with a diagnosis of osteoarthritis (OA).
- 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.
- Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.
Key exclusion criteria (20 listed)
- Patients who require revision of a previously implanted hip prosthesis.
- Patients who had a THA on contralateral side within the last 6 months.
- 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).
- Patients who will need lower limb joint replacement for another joint within one year.
- Patients requiring bilateral hip replacement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accolade stemTotal hip replacement | Device | Accolade stem |
| Accolade II stemTotal hip replacement | Device | Accolade II stem |
| Trident/Tritanium cupTotal hip replacement | Device | Accolade II stem, Accolade stem |
Primary outcome
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).
3 secondary outcomes
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire
Time frame: pre-operative, 1, 3, 5, 7 and 10 years follow-up
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
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire
Time frame: pre-operative, 1, 3, 5, 7 and 10 years follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Bolder, MD principal investigator
Amphia Zieknhuis Breda
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accolade stem, Accolade II stem and Trident/Tritanium cup in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, Belgium, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship of the Device (time frame: 10 years Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.