The ATX registry
| ISRCTN | ISRCTN86833638 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86833638 |
| ClinicalTrials.gov number | NCT02520544 |
| Secondary identifying numbers | ATX20120712 |
- Submission date
- 20/07/2012
- Registration date
- 17/08/2012
- Last edited
- 05/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
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 todays 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 from?
1. Amphia ziekenhuis Breda, Netherlands
2. Ziekenhuis Netwerk Antwerpen, Merksem, Belgium
3. Orbis Medisch Concern Sittard, Netherlands
4. St. Antoniusziekenhuis, Utrecht, Netherlands
5. Rijnstate ziekenhuis Arnhem/Zevenaar, Netherlands
6. Ikazia ziekenhuis Rotterdam, Netherlands
7. Skånevård Kryh, Hässleholm, Sweden
8. Harrogate District Hospital, Harrogate, UK
When is the study starting and how long is it expected to run for?
February 2012 to June 2025
Who is funding the study?
Stryker European Operations BV (Netherlands)
Who is the main contact?
Sietske Witvoet
Contact information
Scientific
Location Molengracht Orthopedie
Postbus 90158
Breda
4800
Netherlands
Study information
| Study design | Prospective international multicentre surveillance register |
|---|---|
| Primary study design | Observational |
| Secondary study design | Prospective international multicentre surveillance register |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The ATX registry - accolade stem & Trident/Tritanium cup with X3 insert international multicentre surveillance register |
| Study 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 |
| Ethics approval(s) | ETC-AMPHIA Ethics Committee, 20/06/2011, ref: BW/niet WMO nr.080.11 |
| 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 | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 | 1. All intra-operative and post-operative adverse events 2. Standard clinical parameters 3. Harris Hip Score, registered preoperatively and at each follow-up visit 4. Oxford Hip Score, registered preoperatively and at each follow-up visit 5. EQ5D, registered preoperatively and at each follow-up visit |
| Overall study start date | 01/02/2012 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 478 |
| 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 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 subjects 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), Pagets 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 patients 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
- England
- Netherlands
- Sweden
- United Kingdom
Study participating centres
Netherlands
-
Belgium
Netherlands
-
Netherlands
Netherlands
Netherlands
-
Sweden
HG2 7SX
United Kingdom
Sponsor information
Industry
Herikerbergweg 110
Amsterdam
1101 CM
Netherlands
| Website | http://www.stryker.com/ |
|---|---|
"ROR" |
https://ror.org/02nwyam20 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Editorial Notes
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.
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 overall trial end date was changed from 01/09/2023 to 31/12/2024.
3. The target number of participants was changed from 1000 to 450550.
