UMIN-CTR Clinical Trial

Basic information
Public title	The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial
Acronym	The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial
Scientific Title	The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial
Scientific Title:Acronym	The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial
Region	Japan

Condition
Condition	Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of corticosteroid on periarticular injection for pain control following total hip arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain at rest during first 24 hours after surgery
Key secondary outcomes	Pain at rest 48 hours after surgery The number of rescue analgesia until 2 day after surgery Pain during activity until 2 day after surgery Complication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty
Interventions/Control_2	A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled for unilateral total hip arthroplasty
Key exclusion criteria	Patients scheduled for simultaneous bilateral total hip arthroplasty. Patients scheduled for revision total hip arthroplasty. Patients scheduled for total hip arthroplasty with shortening subtrochanteric osteotomy. Patients who had allergy or intolerance to one of the study drugs, regular narcotic use, renal insufficiency and diabetes mellitus.
Target sample size	120

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kenji Kurosaka
Organization	Hokusuikai Kinen Hospital
Division name	Orthopaedic surgery
Zip code
Address	3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL	029-303-3003
Email	kenjikurosaka@yahoo.co.jp

Public contact
1st name of contact person	1st name Middle name Last name Kenji Kurosaka
Organization	Hokusuikai Kinen Hospital
Division name	Orthopaedic surgery
Zip code
Address	3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL	029-303-3003
Homepage URL
Email	kenjikurosaka@yahoo.co.jp

Sponsor
Institute	Hokusuikai Kinen Hospital
Institute
Department

Funding Source
Organization	Hokusuikai Kinen Hospital
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
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

Other administrative information
Date of disclosure of the study information	2018 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	Completed
Date of protocol fixation	2018 Year 04 Month 26 Day
Date of IRB	2018 Year 04 Month 21 Day
Anticipated trial start date	2018 Year 06 Month 20 Day
Last follow-up date	2019 Year 03 Month 23 Day
Date of closure to data entry	2019 Year 03 Month 23 Day
Date trial data considered complete	2019 Year 03 Month 23 Day
Date analysis concluded	2019 Year 03 Month 23 Day

Other
Other related information

Management information
Registered date	2018 Year 06 Month 19 Day
Last modified on	2019 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037676