Clinical trial NCT02520544: ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert
Official title: THE ATX REGISTRY ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert International Multicentre Surveillance Register
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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).

Primary outcomes:
measure: Survivorship of the device
timeFrame: 10 years Follow-up
Secondary outcomes:
measure: Investigation of clinical performance and patient outcome with Harris Hip Score (HHS) patient questionnaire
timeFrame: pre-operative, 1, 3, 5, 7 and 10 years follow-up
measure: Investigation of clinical performance and patient outcome with Oxford Hip Score patient questionnaire
timeFrame: pre-operative, 1, 3, 5, 7 and 10 years follow-up
measure: Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire.
timeFrame: pre-operative, 1, 3, 5, 7 and 10 years follow-up
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maatschap Orthopaedie Ikazia
city: Sittard
country: Netherlands
facility: Orbis Medisch Concern
city: Zevenaar
country: Netherlands
facility: Rijnstate Arnhem
city: Hässleholm
country: Sweden
facility: Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm
city: Harrogate
country: United Kingdom
facility: Harrogate and District NHS Foundation Trust
Study officials:
affiliation: Amphia Zieknhuis Breda
name: Stefan Bolder, MD
role: PRINCIPAL_INVESTIGATOR
References: