UMIN-CTR Clinical Trial

Basic information
Public title	Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus.
Acronym	Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus.
Scientific Title	Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus.
Scientific Title:Acronym	Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus.
Region	Japan

Condition
Condition	Osteoarthritis of the knee
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is the comparison between the clinical outcome of the higher tibial osteotomy with meniscal treatment and without meniscal treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	KOOS: Knee injury and Osteoarthritis Outcome Score,Knee society score,Lysholm score, NRS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Arthroscopic centralization of an extruded medial meniscus while the higher tibial osteotomy.
Interventions/Control_2	the higher tibial osteotomy only.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Knee OA jiont space kissing <1cm unicompartment OA meniscus extrusion >3mm or 3mm
Key exclusion criteria	Knee range of motion flexion angle <120 flexion contracture>10 FTA >190 ACL instability knee FTA >190
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Katagiri
Organization	Tokyo Medical and Dental University
Division name	Department of Joint Surgery and Sports Medicine,
Zip code	113-8519
Address	1-5-45 yushima bunkyouku tokyo
TEL	03-5803-4675
Email	katagiri.orj@tmd.ac.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Katagiri
Organization	Tokyo Medical and Dental University
Division name	Department of Joint Surgery and Sports Medicine,
Zip code	113-8519
Address	1-5-45 yushima bunkyouku tokyo
TEL	03-5803-4675
Homepage URL
Email	katagiri.orj@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Donation (1707 Senior Researcher Hideyuki Koga)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University Hospital Hospital Clinical Research Review Committee
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel	03-5803-4675
Email	katagiri.orj@tmd.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	2018 Year 02 Month 05 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	2018 Year 02 Month 05 Day
Date of IRB	2018 Year 04 Month 20 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 05 Day
Last modified on	2019 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035569