Arthroplasty, Replacement, Hip
Conditions
Brief summary
The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years.
Detailed 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)
Interventions
DEVICEAccolade stem
Total hip replacement
DEVICEAccolade II stem
Total hip replacement
DEVICETrident/Tritanium cup
Total hip replacement
Sponsors
Stryker Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of the Device | 10 years Follow-up | Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire | pre-operative, 1, 3, 5, 7 and 10 years follow-up | 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 |
| Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire | pre-operative, 1, 3, 5, 7 and 10 years follow-up | 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, each scored from 0-4 (worst to best), giving a final score with a total range of 0-48. A final score of 0 to 19 indicates severe hip arthritis, 20-29 indicates moderate to severe symptoms, 30-39 indicates mild to moderate symptoms, and 40 to 48 indicates satisfactory joint function. |
| Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | pre-operative, 1, 3, 5, 7 and 10 years follow-up | The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and the EQ-5D descriptive system, time trade-off (TTO). 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. The TTO index values on a scale between -1(low) and 1(high) show the average health status according to the 5 dimensions. A low score shows worse health, and a high score shows better health. |
Countries
Belgium, Netherlands, Sweden, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORStefan Bolder, MD
Amphia Zieknhuis Breda
Participant flow
Recruitment details
There were 472 participants that were enrolled into the study between January 2012 and February 2015.
Pre-assignment details
Of the 472 participants enrolled, 49 cases were censored and excluded from the final analysis. 23 cases did not have a study device implanted, 4 cases did not have their surgery performed, 1 case voluntarily withdrew, 1 case had surgery performed after enrolment window, and 20 cases had inclusion/exclusion criteria violations. Of the remaining 423 participants, there were no bilateral cases.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.71 years STANDARD_DEVIATION 7.46 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Belgium | 22 participants |
| Region of Enrollment Netherlands | 312 participants |
| Region of Enrollment Sweden | 32 participants |
| Region of Enrollment United Kingdom | 33 participants |
| Sex: Female, Male Female | 161 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 18 / 289 | 8 / 134 |
| other Total, other adverse events | 36 / 289 | 41 / 134 |
| serious Total, serious adverse events | 92 / 289 | 56 / 134 |
Outcome results
None listed