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

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

Detailed Description
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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)

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

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Accolade stem
* Device: Accolade II stem
* Device: Trident/Tritanium cup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and non-pregnant female patients between 18-75 years of age. Patients requiring uncemented primary THA (Total Hip Arthroplasty), suitable for the use of the Accolade stem and Trident/Tritanium cup. Patients with a diagnosis of osteoarthritis (OA). 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. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery. Exclusion Criteria: Patients who require revision of a previously implanted hip prosthesis. Patients who had a THA on contralateral side within the last 6 months. 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). Patients who will need lower limb joint replacement for another joint within one year. Patients requiring bilateral hip replacement. Patients who have had a prior procedure of acetabular osteotomy. Patients with acute femoral fractures 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). Patients with active or suspected infection. Patients with malignancy - active malignancy. Patients with severe osteoporosis, rheumatoid arthritis (RA), Paget's disease or renal osteodystrophy. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 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. Female patients planning a pregnancy during the course of the study. Patients with systemic or metabolic disorders leading to progressive bone deterioration. 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. Patients with other severe concurrent joint involvements, which can affect their outcome. 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. Patient with a known sensitivity to device materials. Patients under the protection of law (e.g. guardianship).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Accolade stem<br>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. | Device: Accolade stem<br>* Total hip replacement<br>Device: Trident/Tritanium cup<br>* Total hip replacement<br>|
| Active Comparator: Accolade II stem<br>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. | Device: Accolade II stem<br>* Total hip replacement<br>Device: Trident/Tritanium cup<br>* Total hip replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of clinical performance and patient outcome with HHS (Harris Hip Score) 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 | 
| 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 | 
| Investigation of clinical performance and patient outcome with EuroQuol-5 dimension patient questionnaire (EQ-5D ) | The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status. | pre-operative, 1, 3, 5, 7 and 10 years follow-up |