Multicenter clinical study to evaluate the wear resistance of the BIOCERAM AZUL head in total hip arthroplasty

Multicenter clinical study to evaluate the wear resistance of the BIOCERAM AZUL head in total hip arthroplasty - AZUL study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026999

Enrollment

Registered

2017-04-21

Start date

2017-04-24

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 joint disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with an indication for primary THA as for an operative hip, and consented to the operation(both hips surgery possible). 2)Patients suitable for 32mm and 36mm demoral heads. 3)Patients aged from 20 to 75 years at the time of awritten consent, and the consent to participate in this clinical study is obtaioned before THA (Not gender specific).

Exclusion criteria

Exclusion criteria: 1)Patients whose weight is over 90kg, the weight restriction of the femoral components to be used. 2)Patients who are difficult to be followed for 5 years after THA(in cases that emergency treatments are expected during observation period such as patients recieving hemodialylsis and anticancer drug therapies, or patients will move) 3)Patients whose functions of the implanted device are difficult to evaluate due to of other organs such as heart and nervous system. 4)Patients who are evaluated to be unsuitable for subjects of this study by invetigators.

Design outcomes

Primary

Measure	Time frame
Linear wear of polyethylene liner	—

Countries

Japan

Contacts

Public ContactDai Miyasaka

Niigata University Medical and Dental Hospital Division of Orthpaedic Surgery

miyasakad@yahoo.co.jp025-227-2272

Outcome results