Study on osteoconductivity of the new bone-graft substitute

JRCT ID: jRCTs072180088

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Knee osteoarthritis
• Date of first enrollment: 12/03/2018
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Transplantation of artificial bone (AFFINOS) to 5 patients with knee osteoarthritis.

Outcome(s)

• Primary Outcome: The change of bone microarchitecture from 0 months after surgery to 12 months.

Secondary Outcome

1.The change of bone microarchitecture from 0 months after surgery to 3, 6 and 9 months.
2.The change of bone mineral density and estimated bone strength from 0 months after surgery to 3, 6, 9 and 12 months.

Key inclusion & exclusion criteria

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

Include criteria

The patient with knee osteoarthritis, scheduled to have tibial osteotomy.
A written informed consent for the participation in the study.

• Exclude criteria: Patients judged to be inadequate for this study by investigators.

Related Information

• Primary Sponsor: Osaki Makoto
• Secondary Sponsor: Chiba Ko
• Source(s) of Monetary Support: KURARAY CO., LTD.
• Secondary ID(s): UMIN000030804