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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032772
Receipt No. R000037387
Scientific Title A leg press exercise restoring screw-home movement improves short-term clinical outcomes after opening wedge high tibial osteotomy
Date of disclosure of the study information 2018/05/31
Last modified on 2018/05/30

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Basic information
Public title A leg press exercise restoring screw-home movement improves short-term clinical outcomes after opening wedge high tibial osteotomy
Acronym A leg press exercise restoring screw-home movement improves short-term clinical outcomes after OWHTO
Scientific Title A leg press exercise restoring screw-home movement improves short-term clinical outcomes after opening wedge high tibial osteotomy
Scientific Title:Acronym A leg press exercise restoring screw-home movement improves short-term clinical outcomes after OWHTO
Region
Japan

Condition
Condition Opening wedge high tibial osteotomy
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effectiveness of postoperative exercise with tibial internal rotation on improving clinical outcomes after opening wedge high tibial osteotomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of patient who achieved unsupported gait at one month postoperatively
Key secondary outcomes WOMAC, gait speed

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Exercise with tibial internal rotation (1 months) (tibial internal-external rotation with knee bending, Leg flexion/extension with tibial internal-rotation)
10 repetitions*5 sets
Interventions/Control_2 Traditional knee rehabilitation(1 months)
(Straight leg raising exercise with maximal quadriceps setting)
10 repetitions*5 sets
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 (a) Japanese males and females, (b) between 40 and 80 years old, (c) extension deficit<10 degrees, (d) radiographic severity classified using Kellgren-Lawrence System was grade II to III, (e) agreement of undergoing OWHTO
Key exclusion criteria (a) history of a lower extremity trauma, (b) rheumatoid arthritis, (c) medical risk, and (d) postoperative compartment syndrome after HTO
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Gamada
Organization Graduate School of Hiroshima International University
Division name Department of Medical Technology and Health Welfare Sciences
Zip code
Address 555-36, Kurosegakuendai, Higashihiroshima
TEL +81823704550
Email kazgamada@ortho-pt.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Hoshi
Organization Graduate School of Hiroshima International University
Division name Department of Medical Technology and Health Welfare Sciences
Zip code
Address 555-36, Kurosegakuendai, Higashihiroshima
TEL +81823704550
Homepage URL
Email pt.hoshiken@gmail.com

Sponsor
Institute Hiroshima International University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福岡リハビリテーション病院(福岡県)
Fukuoka Rehabilitation Hospital (Fukuoka)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 31 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 Completed
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 08 Month 31 Day
Date trial data considered complete
2018 Year 08 Month 31 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 30 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037387

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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