Unique ID issued by UMIN | UMIN000048449 |
---|---|
Receipt number | R000055214 |
Scientific Title | Prospective multi-center study on AC Plate evaluating safety and clinical performance in HTO cohort |
Date of disclosure of the study information | 2022/08/04 |
Last modified on | 2023/07/25 09:26:29 |
An observational study on AC Plate in patients with High Tibial Osteotomy
AC Plate study
Prospective multi-center study on AC Plate evaluating safety and clinical performance in HTO cohort
AC Plate study
Japan |
Knee Osteoarthritis
Orthopedics |
Others
NO
The objective of this study is to document the safety and clinical performance on HTO using AC Plate.
Efficacy
Confirmatory
Not applicable
The incidence of Device Deficiency and Adverse Event for which the causal relationship with study device cannot be denied.
The degree of improvement in knee function, knee pain, and quality of life (QOL) as well as the relationship between the plate and irritation.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
(1) 18 years and over.
(2) When using bone filling material, patients who use Affinos in compliance with the IFU (whether or not to use bone filling material or autograft is entrusted to surgeons).
(3) Willing and able to complete scheduled follow-up evaluations as described in the study protocol.
(4) Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent.
(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.
100
1st name | Takuaki |
Middle name | |
Last name | Yamamoto |
Fukuoka University
Department of Orthopaedic Surgery, Faculty of Medicine
814-0180
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
080-2025-0040
akira.kashima@zimmerbiomet.com
1st name | Akira |
Middle name | |
Last name | Kashima |
Zimmer Biomet G.K.
Clinical Affairs
154-0002
2-11-1 Shibakoen, Minato-ku, Tokyo, Japan
080-2025-0040
akira.kashima@zimmerbiomet.com
Zimmer Biomet G.K.
Zimmer Biomet G.K.
Profit organization
Fukuoka University - Medical Ethics Review Board
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
092-801-1011
fumed-ethics@fukuoka-u.ac.jp
NO
2022 | Year | 08 | Month | 04 | Day |
Unpublished
Open public recruiting
2022 | Year | 05 | Month | 09 | Day |
2022 | Year | 12 | Month | 12 | Day |
2023 | Year | 04 | Month | 06 | Day |
2027 | Year | 04 | Month | 30 | Day |
2027 | Year | 05 | Month | 31 | Day |
2027 | Year | 06 | Month | 15 | Day |
2027 | Year | 07 | Month | 15 | Day |
The relationship between AC Plate and adverse events and clinical outcomes including irritation around the plate implanted will be evaluated.
2022 | Year | 07 | Month | 25 | Day |
2023 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055214
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