Osteoarthritis/hip joint Musculoskeletal Diseases Polyarthrosis, unspecified
Conditions
Interventions
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
Sponsors
Stryker European Operations BV (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Netherlands, Sweden, United Kingdom
Outcome results
None listed