NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs072200003

Registered date:10/04/2020

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedKnee osteoarthritis
Date of first enrollment15/04/2020
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)Transplantation of artificial bone (Affinos or OSferion 60) at the operation of tibial osteotomy

Outcome(s)

Primary OutcomeThe differences of bone microarchitecture between Affinos and OSferion 60 at 12 months after the surgery
Secondary OutcomeThe 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 maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Ko Chiba
Address 1-7-1 Sakamoto, Nagasaki City, Nagasaki Pref, Japan Nagasaki Japan 852-8501
Telephone +81-95-819-7321
E-mail ko-chiba@umin.ac.jp
Affiliation Nagasaki University Graduate School of Biomedical Scienses
Scientific contact
Name Makoto Osaki
Address 1-7-1 Sakamoto, Nagasaki City, Nagasaki Pref, Japan Nagasaki Japan 8528501
Telephone +81-95-819-7321
E-mail mosaki@nagasaki-u.ac.jp
Affiliation Nagasaki University Graduate School of Biomedical Scienses