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

Arthroplasty, Replacement, Hip Clinical Trial

— ATX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02520544
• Other study ID #: H-S-038
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2012
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 497
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Accolade stem
Total hip replacement
• Accolade II stem
Total hip replacement
• Trident/Tritanium cup
Total hip replacement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Countries where clinical trial is conducted

Belgium,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Investigation of clinical performance and patient outcome with 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
Secondary	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. Grading 0 to 19 indicate severe hip arthritis, 40 to 48 indicate satisfactory joint function.	pre-operative, 1, 3, 5, 7 and 10 years follow-up
Secondary	Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire.	The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. 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, where an overall score of 1 represents full health.	pre-operative, 1, 3, 5, 7 and 10 years follow-up