Condition category
Musculoskeletal Diseases
Date applied
20/07/2012
Date assigned
17/08/2012
Last edited
15/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Total hip replacement is one of the most common and successful techniques used in orthopaedic surgery. Along with cemented hip replacements, cementless hip replacement has proven its value. Still, the survival of hip implants is not indefinite. Over the years knowledge on stability, fixation and preservation of bone stock has increased considerably. Better understanding of joint movement also allow us to design implants with reduced joint reaction forces, which again may lead to improved survival of implants. The Stryker Accolade™ Femoral Component is a relatively new hip system constructed from a beta titanium alloy (TMZF®). The alloy, which can offer greater flexibility and higher tensile strength than standard titanium alloys, has an elasticity modulus (stiffness) that is closer to that of bone. The upper half of the stem is coated with a hydroxyapatite (HA) coating, which assists in bone ingrowth and provides a good interface for fixation of the stem. The Accolade II stem is an evolution of the Accolade TMZF stem. The size-specific fit of the stem has been redesigned to fit a broad range of bones sizes and shapes found in today’s patient population. The aim of this study is to determine the safety and survivorship of the Accolade/Accolade II stem and the Trident/Tritanium cup over 10 years and to document the patients’ clinical outcome and satisfaction.

Who can participate?
All patients eligible for a hip arthroplasty surgery involving the Accolade or Accolade II stem and Trident or Tritanium cup who have been informed about this surveillance register and who freely consent to participate.

What does the study involve?
The study involves the routine assessment of a hip arthroplasty procedure. Patients who participate in the study will be invited for routine visits and during each visit the patient will be asked to complete one questionnaire about their health and one about their activities and their hip. Follow-ups take place at 1, 3, 5, 7 and 10 years after the surgery.

What are the possible benefits and risks of participating?
Patient benefits should include relief of pain and increase in functional capabilities, in addition to better assessment of the effect of prosthesis design and materials on functional and radiographic performance and bone remodelling around cementless femoral prostheses. This will increase the current scientific body of knowledge concerning total hip arthroplasty. As with any surgical procedure, certain risks are associated with total joint arthroplasty. These risks include but are not limited to: anaesthetic and post-anaesthetic reactions (such as hyperaemia), allergic reactions to prophylactic antibiotics or blood transfusions, damage to blood vessels or nerves, trochanteric or femoral fractures during implantation, perforation of the cortical wall, or death. After the operation, a patient may experience thrombophlebitis, pulmonary embolus, dislocation, pain, limp, component loosening, osteolysis due to wear debris or the need for additional surgery. Fracture of the prosthesis is a potential complication. Pre-clinical, clinical and mechanical testing of the Stryker Accolade and Accolade II Hip Stem and Trident/Tritanium cup indicate that the above mentioned risks should not occur at a rate greater than that of any other type of total hip arthroplasty reported in the literature.

Where is the study run?
The following eight centers participate in this registry:
1. Amphia ziekenhuis Breda, The Netherlands
2. Ziekenhuis Netwerk Antwerpen, Merksem, Belgium
3. Orbis Medisch Concern Sittard, The Netherlands
4. St. Antoniusziekenhuis, Utrecht, The Netherlands
5. Rijnstate ziekenhuis Arnhem/Zevenaar, The Netherlands
6. Ikazia ziekenhuis Rotterdam, The Netherlands
7. Skånevård Kryh, Hässleholm, Sweden
8. Harrogate District Hospital, Harrogate, United Kingdom

When is the study starting and how long is it expected to run for?
The study started in January 2012 and inclusion was open until February 2015. After enrolment, all patients will be followed for 10 years. Study closure is expected in 2025.

Who is funding the study?
Stryker European Operations BV (Netherlands)

Who is the main contact?
Sietske Witvoet

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefan Bolder

ORCID ID

Contact details

Location Molengracht Orthopedie
Postbus 90158
Breda
4800
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02520544

Protocol/serial number

ATX20120712

Study information

Scientific title

The ATX registry - accolade stem & Trident/Tritanium cup with X3 insert international multicentre surveillance register

Acronym

ATX

Study hypothesis

1. Clinical outcome is as good as or better than published results of other press-fit stems
2. Similar clinical results can be obtained with non-designer surgeons as compared to the designer surgeons
3. Tapered stems perform well in all patient populations

On 26/08/2014 the following changes were made to the trial record:
1. Sweden and the United Kingdom were added to the countries of recruitment
2. The anticipated end date was changed from 01/09/2023 to 31/12/2024
3. The target number of participants was changed from 1000 to 450–550

Ethics approval

ETC-AMPHIA Ethics Committee, 20/06/2011, ref:BW/niet WMO nr.080.11

Study design

Prospective international multicentre surveillance register

Primary study design

Observational

Secondary study design

Other

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Osteoarthritis/hip joint

Intervention

No comparative treatments here. This is a follow-up register of one cohort of patients undergoing total hip arthroplasty. Follow-ups are due at 1, 3, 5, 7 and 10 years

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. To verify the Accolade/Accolade II stem and Trident/Tritanium cup safety during follow-up and survivorship as described by Kaplan-Meier survival curves
2. To document the patient clinical outcome of the patients who are eligible for a hip arthroplasty surgery involving an Accolade/Accolade II stem and Trident/Tritanium cup

Secondary outcome measures

The following parameters/scores are collected:
1. All intra-operative and post-operative adverse events
2. Standard clinical parameters
3. Harris Hip Score will be registered preoperatively and at each follow-up visit
4. Oxford Hip Score will be registered preoperatively and at each follow-up visit
5. EQ5D will be registered preoperatively and at each follow-up visit

Overall trial start date

01/02/2012

Overall trial end date

30/06/2025

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 26/08/2014:
1. Male and non-pregnant female patients between 18-75 years of age
2. Patients requiring uncemented primary 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

Previous inclusion criteria:
1. Male and non-pregnant female patients between 18-70 years of age
2. Patients requiring uncemented primary 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

478

Participant 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 their 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 place 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)

Recruitment start date

01/02/2012

Recruitment end date

28/02/2015

Locations

Countries of recruitment

Belgium, Netherlands, Sweden, United Kingdom

Trial participating centre

Location Molengracht Orthopedie
Breda
4800
Netherlands

Sponsor information

Organisation

Stryker European Operations BV (Netherlands)

Sponsor details

Herikerbergweg 110
Amsterdam
1101 CM
Netherlands

Sponsor type

Industry

Website

http://www.stryker.com/

Funders

Funder type

Industry

Funder name

Stryker SA (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 15/12/2015 the following changes were made to the trial record: 1. The overall trial end date was changed from 31/12/2024 to 30/06/2025. 2. The target number of participants was changed from 450–-550 to 478.