UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Different surgical techniques in THA and its effect on periprosthetic BMD
Title of the study (Brief title)	Different surgical techniques in THA and its effect on periprosthetic BMD
Region	Japan

Condition
Condition	osteoarthritis of the hip
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of different surgical techniques for primary THA on periprosthetic local bone remodeling.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	periprosthetic BMD at 6months after surgery.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	to intentionally preserve cancellous bone around the prosthesis during implantation during primary THA
Interventions/Control_2	implanting a femoral component with standard technique without intentionally preserving cancellous bone around the prosthesis
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	80 years-old >
Gender	Female
Key inclusion criteria	Patients who are planned to undergo THA with written IC
Key exclusion criteria	patients without written IC.
Target sample size	50

Research contact person
Name of lead principal investigator	Arihiko Kanaji
Organization	Keio University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	0333531211
Email	hikokanaji@gmail.com

Public contact
Name of contact person	Toru Nishiwaki
Organization	Keio University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	0333531211
Homepage URL
Email	tornish0722@yahoo.co.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 03 Month 23 Day
Anticipated trial start date	2015 Year 07 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	2015 Year 06 Month 25 Day
Last modified on	2017 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020927