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) studied | Knee Osteoarthritis |
Date of first enrollment | 2023/04/06 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | The incidence of Device Deficiency and Adverse Event for which the causal relationship with study device cannot be denied. |
---|---|
Secondary Outcome | The 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 minimum | 18years-old |
---|---|
Age maximum | Not applicable |
Gender | Male 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
Primary Sponsor | Zimmer Biomet G.K. |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | Zimmer Biomet G.K. |
Secondary ID(s) |
Contact
public contact | |
Name | Akira Kashima |
Address | 2-11-1 Shibakoen, Minato-ku, Tokyo, Japan Japan 154-0002 |
Telephone | 080-2025-0040 |
akira.kashima@zimmerbiomet.com | |
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 |
akira.kashima@zimmerbiomet.com | |
Affiliation | Fukuoka University Department of Orthopaedic Surgery, Faculty of Medicine |