The study of bioresorbable bone-graft substitute Affinos and OSferion in bone osteoconductivity
Not Applicable
- Conditions
- Knee osteoarthritisD020370
- Registration Number
- JPRN-jRCTs072200003
- Lead Sponsor
- Osaki Makoto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
(1) The patient with knee osteoarthritis, scheduled to have tibial osteotomy.
(2) Age: Patients over 20 years old
(3) Gender: male and female
(4) After receiving sufficient explanation for participation in this study, patients who gained written consent by the patient's free will with sufficient understanding.
Exclusion Criteria
(1) Pregnant patients, patients who may be pregnant, patients hoping to become pregnant during the study period
(2) Sever renal impairment (eGFR< 30 mL/min./1.73 m2)
(3) Patients who have malignant tumor
(4) Patients judged to be inadequate for this study by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The differences of bone microarchitecture between Affinos and OSferion 60 at 12 months after the surgery
- Secondary Outcome Measures
Name Time Method The differences of bone microarchitecture between Affinos and OSferion 60 at 0, 3, 6, 9 months after the surgery<br>The changes of bone microarchitecture 60 from 0 months after surgery to 3, 6, 9, 12 months.<br>The changes of simulated bone strength 60 from 0 months after surgery to 3, 6, 9, 12 months.<br>The changes of KOOS score 60 from 0 months after surgery to 3, 6, 9, 12 months.<br>The dulation required to remove the implants