Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, hip
Treatments accolade stem, accolade ii stem, trident/tritanium cup
Sponsor Stryker European Operations BV
Start date January 2012
End date February 2025
Trial size 497 participants
Trial identifier NCT02520544, H-S-038

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
accolade stem
Total hip replacement
trident/tritanium cup
Total hip replacement
(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.
accolade ii stem
Total hip replacement
trident/tritanium cup
Total hip replacement

Primary Outcomes

Measure
Survivorship of the device
time frame: 10 years Follow-up

Secondary Outcomes

Measure
Investigation of clinical performance and patient outcome with HHS (Harris 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 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 patient questionnaire (EQ-5D )
time frame: pre-operative, 1, 3, 5, 7 and 10 years follow-up

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title THE ATX REGISTRY ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert International Multicentre Surveillance Register
Principal investigator Stefan Bolder, MD
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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Stryker European Operations BV.