UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Randomized Trial of Hyaluronan Injection Efficacy for Long-term Prognosis in Knee Osteoarthritis
Title of the study (Brief title)	HELP Study for Knee OA
Region	Japan

Condition
Condition	knee osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	One year outcome comparison between 5-time weekly hyaluronan injection group and 5-time weekly injection with monthly repetitive injection group
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	patient-based subjective assessment
Key secondary outcomes	Radiographic assessment, MRI evaluation and physical evaluation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention/ 5-time weekly hyaluronan injection combined with monthly repetitive injections
Interventions/Control_2	Control / Only 5-time weekly hyaluronan injection
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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients who show Kellgren-Lawrence grade 1-3 knee osteoarthritis within 3 months 2. Pateints who did not receive hyaluronan injection therapy within recent 3 months 3. Patients who suffer from knee pain 4. Patients who give a written consent to the study
Key exclusion criteria	1. Patients who have neurological and/or vascular complications which may affect the evaluation 2. Patients who have difficulty for evaluation because of their physical and/or mental condition 3. Patients who take not allowed medication for treatment of pain 4. Patients who have ill controlled DM, etc. 5. Patients who have possibility of taking other surgical treatments within a year 6. Patients who live distant from the hospital with difficulty of visiting frequently
Target sample size	360

Research contact person
Name of lead principal investigator	Takeshi Muneta
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopaedic Surgery, Hospital for Medicine
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	+81358035953
Email	muneta.orj@tmd.ac.jp

Public contact
Name of contact person	Kunikazu Tsuji
Organization	Tokyo Medial and Dental University
Division name	Department of Cartilage Regeneration, Graduate School
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	+8158034080
Homepage URL
Email	tsuji.orj@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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	東京医科歯科大学病院（東京都）、弘前大学病院（青森県）、船橋整形外科（千葉県）、三菱名古屋病院（愛知県）、兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 19 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 04 Month 20 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 18 Day
Last modified on	2016 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019988