UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach
Acronym	Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach
Scientific Title	Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach
Scientific Title:Acronym	Evaluation of Functional Recovery After Total Hip Arthroplasty Performed Through AMIS versus Direct Lateral Approach
Region	Japan

Condition
Condition	Total Hip Arthroplasty
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of Functional Recovery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HOOS modified score
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	Maneuver
Interventions/Control_1	AMIS vs Direct Lateral Approach
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	55 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Male and female aged 55-75 years at time of surgery 2.Patients who are candidate for primary total hip arthroplasty. 3.Patients are categorized Type I or II on Crowe classification, or ION. 4.Patients have informed consent. 5. Patients deemed capable of understanding the aims of the study and expressing willingness to comply with the post-operative review program
Key exclusion criteria	1.Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems 2.Those already treated by with a THR (i.e. requiring a revision hip replacement). 3.Patients suffering from back diseases or ipsilateral knee pathologies 4.Patients treated by with a contralateral hip replacement or presenting contralateral hip diseases. 5.Patients requiring a bilateral total hip replacement 6.Patients whose BMI exceeds 40 7.Any case not described in the inclusion criteria
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Etsuo Middle name Last name Chosa
Organization	University of Miyazaki Hospital
Division name	Department of Orthopaedic Surgery
Zip code	889-1692
Address	5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL	0985-85-0986
Email	seikei@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Etsuo Middle name Last name Chosa
Organization	University of Miyazaki Hospital
Division name	Department of Orthopaedic Surgery
Zip code	889-1692
Address	5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL	0985-85-0986
Homepage URL
Email	seikei@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki Hospital
Institute
Department

Funding Source
Organization	Medacta Japan Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Support Center
Address	5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
Tel	0985-85-9403
Email	igakubu_kenkyu@med.miyazaki-u.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	2018 Year 02 Month 01 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	2017 Year 12 Month 02 Day
Date of IRB	2018 Year 05 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 10 Day
Last modified on	2020 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035118