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

UMIN ID: UMIN000048449

Registered date:04/08/2022

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

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
• 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.
• Source(s) of Monetary Support: Zimmer Biomet G.K.