UMIN-CTR Clinical Trial

Basic information
Public title	Accuracy of AR navigation for cup placement in total hip arthroplasty
Acronym	Accuracy of AR navigation for cup placement in total hip arthroplasty
Scientific Title	Accuracy of AR navigation for cup placement in total hip arthroplasty
Scientific Title:Acronym	Accuracy of AR navigation for cup placement in total hip arthroplasty
Region	Japan

Condition
Condition	Osteoarthritis, Osteonecrosis of femooral head,Rapidly destructive coxarthropathy,Rheumatoid arthritis, Femoral neck fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the accuracy of cup placement with AR navigation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cup position
Key secondary outcomes	Operative factors, Clinical score, Postoperative course

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cup is positioned with AR navigation
Interventions/Control_2	Cup is positioned without navigation
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.Osteoarthritis, Osteonecrosis of femoral head, Rapidly destractive coxarthropathy, Rheumatoid arthritis, Femoral neck fracture 2.20 years old or >20 years old 3.Willingness to participate 4.One side of hip joint, even if bilateral hip disease
Key exclusion criteria	1.Neurological disease, Difficult to follow phyician instructions 2.Osteomalacia, Severe osteoporosis 3.Metabolic disease affecting bone 4.Infection around hip joint 5.Severe bone defect 6.Not suitable for the clinical trial judged by physician
Target sample size	72

Research contact person
Name of lead principal investigator	1st name Hiromasa Middle name Last name Tanino
Organization	Asahikawa Medical University
Division name	Department of Orthopaedic Surgery
Zip code	078-8510
Address	Midorigaoka Higashi 2-1-1-1, Asahikawa
TEL	0166-68-2512
Email	tanino@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Hiromasa Middle name Last name Tanino
Organization	Asahikawa Medical University
Division name	Department of Orthopaedic Surgery
Zip code	078-8510
Address	Midorigaoka Higashi 2-1-1-1, Asahikawa
TEL	0166-68-2512
Homepage URL
Email	tanino@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	No funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Asahikawa Medical University
Address	Midorigaoka Higashi 2-1-1-1, Asahikawa
Tel	0166-65-2111
Email	rs-kk.g@asahikawa-med.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	2021 Year 08 Month 16 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	No longer recruiting
Date of protocol fixation	2021 Year 07 Month 19 Day
Date of IRB	2021 Year 07 Month 21 Day
Anticipated trial start date	2021 Year 08 Month 27 Day
Last follow-up date	2023 Year 09 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	2021 Year 07 Month 28 Day
Last modified on	2022 Year 08 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051392