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

NCT02520544 | Completed Results

• 1 other identifier: H-S-038
• Study Type: interventional
• Target: 472
• Locations: 4 countries
• Sites: 8

Brief Summary

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

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire

  pre-operative, 1, 3, 5, 7 and 10 years follow-up

• 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

Study Arms (2)

Accolade stem

ACTIVE COMPARATOR

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; Device: Trident/Tritanium cup

Accolade II stem

ACTIVE COMPARATOR

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; Device: Trident/Tritanium cup

Interventions

Accolade stem DEVICE

Total hip replacement

Accolade stem

Accolade II stem DEVICE

Total hip replacement

Accolade II stem

Trident/Tritanium cup DEVICE

Total hip replacement

Accolade II stem; Accolade stem

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (8)

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Maatschap Orthopaedie Ikazia

Rotterdam, Netherlands

Location

Orbis Medisch Concern

Sittard, Netherlands

Location

Rijnstate Arnhem

Zevenaar, Netherlands

Location

Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm

Hässleholm, Sweden

Location

Harrogate and District NHS Foundation Trust

Harrogate, United Kingdom

Location

Limitations and Caveats

Registry-based study Modified HHS scores reported as unable to collect physical measurements in-person due to COVID-19 pandemic.

Results Point of Contact

• Title: Kevin Barga, Director, Clinical Affairs
• Organization: Stryker Orthopaedics

kevin.barga@stryker.com

201-831-5000

Study Officials

• Stefan Bolder, MD

  Amphia Zieknhuis Breda

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: August 13, 2015
• Study Start: January 1, 2012
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2025-10

Locations

GB (1); BE (1); SE (1); NL (5)