UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A leg press exercise restoring screw-home movement improves short-term clinical outcomes after opening wedge high tibial osteotomy
Title of the study (Brief title)	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	Kazuyoshi Gamada
Organization	Graduate School of Hiroshima International University
Division name	Department of Medical Technology and Health Welfare Sciences
Address	555-36, Kurosegakuendai, Higashihiroshima
TEL	+81823704550
Email	kazgamada@ortho-pt.com

Public contact
Name of contact person	Kenji Hoshi
Organization	Graduate School of Hiroshima International University
Division name	Department of Medical Technology and Health Welfare Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 01 Day
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

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Publication of results	Unpublished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