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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048449
Receipt No. 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 2022/07/25

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Basic information
Public title An observational study on AC Plate in patients with High Tibial Osteotomy
Acronym AC Plate study
Scientific Title Prospective multi-center study on AC Plate evaluating safety and clinical performance in HTO cohort
Scientific Title:Acronym AC Plate study
Region
Japan

Condition
Condition Knee Osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to document the safety and clinical performance on HTO using AC Plate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (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.
Key exclusion 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.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takuaki
Middle name
Last name Yamamoto
Organization Fukuoka University
Division name Department of Orthopaedic Surgery, Faculty of Medicine
Zip code 814-0180
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL 080-2025-0040
Email akira.kashima@zimmerbiomet.com

Public contact
Name of contact person
1st name Akira
Middle name
Last name Kashima
Organization Zimmer Biomet G.K.
Division name Clinical Affairs
Zip code 154-0002
Address 2-11-1 Shibakoen, Minato-ku, Tokyo, Japan
TEL 080-2025-0040
Homepage URL
Email akira.kashima@zimmerbiomet.com

Sponsor
Institute Zimmer Biomet G.K.
Institute
Department

Funding Source
Organization Zimmer Biomet G.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuoka University - Medical Ethics Review Board
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
Tel 092-801-1011
Email fumed-ethics@fukuoka-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2022 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2022 Year 09 Month 01 Day
Last follow-up date
2026 Year 08 Month 31 Day
Date of closure to data entry
2026 Year 11 Month 30 Day
Date trial data considered complete
2026 Year 12 Month 31 Day
Date analysis concluded
2027 Year 01 Month 31 Day

Other
Other related information The relationship between AC Plate and adverse events and clinical outcomes including irritation around the plate implanted will be evaluated.

Management information
Registered date
2022 Year 07 Month 25 Day
Last modified on
2022 Year 07 Month 25 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055214

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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