The study of bioresorbable bone-graft substitute Affinos and OSferion in bone osteoconductivity

JRCT ID: jRCTs072200003

Registered date:10/04/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Knee osteoarthritis
• Date of first enrollment: 15/04/2020
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Transplantation of artificial bone (Affinos or OSferion 60) at the operation of tibial osteotomy

Outcome(s)

• Primary Outcome: The differences of bone microarchitecture between Affinos and OSferion 60 at 12 months after the surgery

Secondary Outcome

The differences of bone microarchitecture between Affinos and OSferion 60 at 0, 3, 6, 9 months after the surgery
The changes of bone microarchitecture 60 from 0 months after surgery to 3, 6, 9, 12 months.
The changes of simulated bone strength 60 from 0 months after surgery to 3, 6, 9, 12 months.
The changes of KOOS score 60 from 0 months after surgery to 3, 6, 9, 12 months.
The dulation required to remove the implants

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Osaki Makoto
• Source(s) of Monetary Support: KURARAY CO.,LTD