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Multicenter clinical study to assess the effectiveness and safety of Aquala liner in total hip arthroplasty (THA)

Multicenter clinical study to assess the effectiveness and safety of Aquala liner in total hip arthroplasty (THA) - AQUALA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008730
Enrollment
760
Registered
2012-10-01
Start date
2012-10-01
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 disorders including osteoarthritis

Interventions

Ceramic femoral head Metal femoral head

Sponsors

Graduate School of Medicine, The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are indicated for a primary THA, and entered this study on the basis of their agreement to participate in the clinical trial. Patients who are indicated for this surgery on both sides can be included. 2) Patients who have an indication for the Aquala liner with a femoral head of 28 mm or 32 mm in diameter. 3) Patients aged 75 or younger at the time of a written prior consent to participate in this clinical study(no gender selective).

Exclusion criteria

Exclusion criteria: 1) Patients who are not indicated for a primary THA 2) Patients with unstable clinical conditions 3) Patients whose weight is over the weight restriction of the femoral components to be used 4) Patients who are difficult to be followed for 5 years after the index surgery 5) Patients who are unable to evaluate their own QOL 6) Patients whose functions of the hip joints are difficult to evaluate due to disorders of other organs such as heart and nervous system 7) Patients who once had an artificial hip joint in the same hip joint 8) Patients who are at high risk of thrombosis or bleeding 9) Patients susceptive to infection 10)Patients receiving the anticancer drug therapy 11)Patients who are evaluated to be unsuitable for the subject of this study by the investigators

Design outcomes

Primary

MeasureTime frame
Wear of the polyethylene liner

Countries

Japan

Contacts

Public ContactYoshio Takatori

Graduate School of Medicine, The University of Tokyo Div. Science for Joint Reconstruction

takatori-orth@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026