Multicenter clinical study to assess the effectiveness and safety of Aquala liner in total hip arthroplasty
- Conditions
- Hip disorders including osteoarthritis
- Registration Number
- JPRN-jRCTs032180333
- Lead Sponsor
- Tanaka Takeyuki
- Brief Summary
In this study, we evaluated subjects who were performed primary THA using a research medical device (Aquala liner). As a result, the steady-state wear rate of the Aquala liner was significantly lower than that of the historical control group(p<0.001). Assessment of hip function, activity levels, and health status all improved postoperatively. The survival rate was 98.3%, which was superior to the survival rate for conventional artificial hip joint.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 760
*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.
*Patients who have an indication for the Aquala liner with a femoral head of 28 mm or 32 mm in diameter.
*Patients who are not indicated for a primary THA
*Patients with unstable clinical conditions
*Patients whose weight is over the weight restriction of the femoral components to be used
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method