UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prospective cohort study of the change of physical activity through the surgical treatment for ankle osteoarthritis patients
Title of the study (Brief title)	The change of physical activity through the surgical treatment for ankle osteoarthritis patients
Region	Japan

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

Objectives
Narrative objectives1	To identify the effectiveness of surgical treatment for the ankle osteoarthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	number of steps
Key secondary outcomes	activity duration pain visual analogue scale Japanese Society for Surgery of the Foot standard rating system Self- Administered Foot Evaluation Questionnaire expectation and satisfaction for operation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	activity monitor for 1 week
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. patients who will have ankle arthrodesis or ankle arthroplasty for ankle osteoarthritis 2. patients who agree with this study through precise instruction and understanding
Key exclusion criteria	1. the past history of foot and ankle operations 2. neuromuscular disease 3. inflammation disease 4. complications which affect physical activity 5. patients who cannot answer the questionnaire 6. daily use of wheel chair 7. revision case 8. patients who reject to participate in this study 9. patients whom a principal investigator assessed as inadequate
Target sample size	50

Research contact person
Name of lead principal investigator	Noriyuki Kanzaki
Organization	Kobe university graduate school of medicine
Division name	Orthopaedic surgery
Address	7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe city
TEL	078-382-5985
Email	kanzaki@med.kobe-u.ac.jp

Public contact
Name of contact person	Noriyuki Kanzaki
Organization	Kobe university graduate school of medicine
Division name	Orthopaedic surgery
Address	7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe city
TEL	078-382-5985
Homepage URL
Email	kanzaki@med.kobe-u.ac.jp

Sponsor
Institute	Kobe university graduate school of medicine
Institute
Department

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

Other related organizations
Co-sponsor	Chiba University, Teikyo University Hospital, Mizonokuchi, Kurume University, St Lukes International Hospital, Hyakutake orthopaedics and Sports Clinic
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	千葉大学(千葉県、Chiba University)、帝京大学医学部付属溝口病院(神奈川県、Teikyo University Hospital, Mizonokuchi)、久留米大学(福岡県、Kurume University)、聖路加国際病院(東京都、St. Luke’s International Hospital)、百武整形外科スポーツクリニック(佐賀県、Hyakutake Orthopaedics and Sports Clinic)

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 19 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 02 Month 20 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035844