CompletedNot Applicable

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

Belgium, Netherlands472 participantsStarted 2012-01

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).

Survivorship of the Device

Timeframe: 10 years Follow-up

NCT IDNCT02520544

SponsorStryker Orthopaedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-12

Results submitted2025-11-18

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).