UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017962 |
|---|---|
| Receipt number | R000019988 |
| Scientific Title | Prospective Randomized Trial of Hyaluronan Injection Efficacy for Long-term Prognosis in Knee Osteoarthritis |
| Date of disclosure of the study information | 2015/06/19 |
| Last modified on | 2016/12/22 13:32:05 |
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Basic information
Public title
Prospective Randomized Trial of Hyaluronan Injection Efficacy for Long-term Prognosis in Knee Osteoarthritis
Acronym
HELP Study for Knee OA
Scientific Title
Prospective Randomized Trial of Hyaluronan Injection Efficacy for Long-term Prognosis in Knee Osteoarthritis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takeshi Muneta |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery, Hospital for Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+81358035953
muneta.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunikazu Tsuji |
Organization
Tokyo Medial and Dental University
Division name
Department of Cartilage Regeneration, Graduate School
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
+8158034080
Homepage URL
tsuji.orj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2015 | Year | 04 | Month | 20 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019988
