Accolade II Multi-center Study on fixation pattern, contact point, between stem and cortical bone by CT image analysis

Accolade II Multi-center Study on fixation pattern, contact point, between stem and cortical bone by CT image analysis - Accolade II CT Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021853

Enrollment

240

Registered

2016-04-11

Start date

2016-04-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip osteoarthritis, osteonecrosis of the femoral head

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients are candidate for a primary THA. 2) Patients are collected CT image postoperatively. 3) Patients have diagnosis of OA, AVN. 4) Patients are age 20 or over. 5) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form 6) Patients are willing and able to comply with postoperative scheduled evaluations

Exclusion criteria

Exclusion criteria: 1) Patients have bacterial infectious disease or have risk highly of bacterial infection. 2) Patients requiring revision surgery of a previously implanted total hip arthroplasty. 3) Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) >40. 4) Patients who is pregnant female or maybe so. 5) Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 6) Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy). 7) Patients who are immunologically suppressed or receiving chronic steroids. 8) Patients who are judged ineligible with reasonable reason by primary doctor.

Design outcomes

Primary

Measure	Time frame
Fixation pattern and contact point between stem and cortical bone	—

Countries

Japan

Contacts

Public ContactKenta Suzuki

Stryker Japan K.K. Clinical Affairs

kenta.suzuki@stryker.com03-6894-8357

Outcome results