NIPH Clinical Trials Search

UMIN ID: UMIN000048449

Registered date:04/08/2022

An observational study on AC Plate in patients with High Tibial Osteotomy

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedKnee Osteoarthritis
Date of first enrollment2023/04/06
Target sample size100
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeThe incidence of Device Deficiency and Adverse Event for which the causal relationship with study device cannot be denied.
Secondary OutcomeThe degree of improvement in knee function, knee pain, and quality of life (QOL) as well as the relationship between the plate and irritation.

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria(1) Is septic, has an active infection or has osteomyelitis at the affected joint. (2) Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery. (3) Has any concomitant disease which is likely to jeopardize the functioning or success of the implant. (4) Scheduled for surgery may affect implant evaluation (including Anterior Cruciate Ligament (ACL) reconstruction). (5) Underwent Double Level Osteotomy (DLO). (6) Has been enrolled to this study with contralateral knee. (7) Is known to be pregnant. (8) Unable to understand what participation in this study entails. (9) Has a known sensitivity or allergy to one or more of the implanted materials. (10) Others deemed inappropriate by investigators.

Related Information


public contact
Name Akira Kashima
Address 2-11-1 Shibakoen, Minato-ku, Tokyo, Japan Japan 154-0002
Telephone 080-2025-0040
Affiliation Zimmer Biomet G.K. Clinical Affairs
scientific contact
Name Takuaki Yamamoto
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan Japan
Telephone 080-2025-0040
Affiliation Fukuoka University Department of Orthopaedic Surgery, Faculty of Medicine