UMIN-CTR Clinical Trial

Basic information
Public title	A new protocol of early rehabilitation after unilateral primary total hip arthroplasty
Acronym	A new protocol of early rehabilitation after unilateral primary total hip arthroplasty
Scientific Title	A new protocol of early rehabilitation after unilateral primary total hip arthroplasty
Scientific Title:Acronym	A new protocol of early rehabilitation after unilateral primary total hip arthroplasty
Region	Japan

Condition
Condition	Osteoarthritis of hip joint
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to evaluate the validity of the new protocol for rehabilitation after unilateral primary total hip arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hospital stay after total hip arthroplasy
Key secondary outcomes

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	Other
Interventions/Control_1	Rihabilitation after total hip arthroplasty during hospital stay.
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	The patients for unilateral primary total hip arthroplasty
Key exclusion criteria	(1)consciousness disorder (2)mental disorder (3)dislocation after the surgery (4)periprosthetic infection (5)motor paralysis
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Chiba
Organization	Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Division name	Orthopaedic Surgery
Zip code	9808547
Address	1-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7245
Email	d-chiba@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Chiba
Organization	Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Division name	Orthopaedic Surgery
Zip code	9808547
Address	1-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL	022-717-7245
Homepage URL
Email	d-chiba@med.tohoku.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Institute
Department

Funding Source
Organization	Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Medicine
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.ac.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 20 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	2020 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date	2020 Year 06 Month 23 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 18 Day
Last modified on	2020 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046605