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

The study of bioresorbable bone-graft substitute Affinos and OSferion in bone osteoconductivity: bone microstructure analysis using high resolution CT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs072200003

Enrollment

Registered

2020-04-10

Start date

2020-04-15

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

Knee osteoarthritis

Interventions

Transplantation of artificial bone (Affinos or OSferion 60) at the operation of tibial osteotomy

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The differences of bone microarchitecture between Affinos and OSferion 60 at 12 months after the surgery	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactKo Chiba

Nagasaki University Graduate School of Biomedical Scienses

ko-chiba@umin.ac.jp+81-95-819-7321

Outcome results

None listed

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