The ATX registry

Completed

Conditions: Osteoarthritis/hip joint
Musculoskeletal Diseases
Polyarthrosis, unspecified

Registration Number: ISRCTN86833638

Lead Sponsor: Stryker European Operations BV (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 478

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

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)