N/A
N=423
ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert
Arthroplasty, Replacement, Hip
Bottom Line
View on ClinicalTrials.gov: NCT02520544 ↗Enrolled (actual)
423
Serious AEs
35.0%
Results posted
Jan 2026
Primary outcome: Primary: Survivorship of the Device — 97.03; 98.27 percentage of participants not revised — p=0.4551
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Accolade stem (Device); Accolade II stem (Device); Trident/Tritanium cup (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Orthopaedics
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survivorship of the Device |
97.03; 98.27 | 0.4551 |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire |
59.73; 58.47; 95.08; 93.34; 94.89; 95.07 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire |
24.55; 22.47; 43.98; 44.20; 44.70; 44.84 | — |
| SECONDARY Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire |
66.8; 66.9; 81.3; 83.1; 79.7; 81.0 | — |
Summary
The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years.
Eligibility Criteria
Inclusion Criteria
- Male and non-pregnant female patients between 18-75 years of age.
- Patients requiring uncemented primary Total Hip Arthroplasty (THA), 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).
Data sourced from ClinicalTrials.gov (NCT02520544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.