UMIN-CTR Clinical Trial

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

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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 or person

Institute

Zimmer Biomet G.K.

Institute

Department

Personal name



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

Open public recruiting

Date of protocol fixation

2022 Year 05 Month 09 Day

Date of IRB

2022 Year 12 Month 12 Day

Anticipated trial start date

2023 Year 04 Month 06 Day

Last follow-up date

2027 Year 04 Month 30 Day

Date of closure to data entry

2027 Year 05 Month 31 Day

Date trial data considered complete

2027 Year 06 Month 15 Day

Date analysis concluded

2027 Year 07 Month 15 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

2023 Year 07 Month 25 Day



Link to view the page

Value
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