UMIN-CTR Clinical Trial

Basic information
Public title	Accelerometer-Based Navigation Versus Conventional Alignment Guide for Acetabular Component Placement in Total Hip Arthroplasty: A Randomized, Controlled Trial: Comparisons of computed tomographic outcomes and liner-to-neck clearances during weight-bearing activities
Acronym	Evaluation of three-dimensional kinematics after primary THA: comparison of accelerometer-based portable navigation system and conventional technique
Scientific Title	Accelerometer-Based Navigation Versus Conventional Alignment Guide for Acetabular Component Placement in Total Hip Arthroplasty: A Randomized, Controlled Trial: Comparisons of computed tomographic outcomes and liner-to-neck clearances during weight-bearing activities
Scientific Title:Acronym	Evaluation of three-dimensional kinematics after primary THA: comparison of accelerometer-based portable navigation system and conventional technique
Region	Japan

Condition
Condition	Secondary osteoarthritis caused by hip dysplasia or osteonecrosis of the femoral head
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate in-vivo kinematics of total hip arthroplasty during daily activities using the accelerometer-based navigation device (HipAlign system, Zimmer Biomet, Warsaw, IN, USA) in comparison with that using conventional alignment guide.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate with the validated image matching technique whether the accelerometer-based navigation device (HipAlign system, Zimmer Biomet, Warsaw, IN, USA) provides significantly larger distances between the acetabular liner and the stem neck (liner-to-neck clearance) during daily activities compared to conventional alignment guide.
Key secondary outcomes	To evaluate with CT images whether the accelerometer-based navigation device (HipAlign system, Zimmer Biomet, Warsaw, IN, USA) provides significantly higher precisions in the acetabular cup alignment compared to conventional alignment guide.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Total hip arthroplasty using conventional alignment guide
Interventions/Control_2	Total hip arthroplasty using accelerometer-based portable navigation system
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) Primary total hip arthroplasty 2) Age: 20- years old 3) Male and Female 4) Patients with the ability of consent and writing 5) Patients who can visit hospital as scheduled during the research period
Key exclusion criteria	1) Patients with immature bone structure 2) Patients with the loss of abduction muscle in affected leg 3) Patients with insufficient bone mineral density (e.g. Corticosteroid-induced metabolic bone disease) 4) Patients with insufficient skin covering around the hip joint 5) Patients with neuromuscular disease (e.g. Charcot disease) in affected leg 6) Patients with the infection (e.g. osteomyelitis in proximal femur or purulent infection in the hip joint) 7) Patients with stovepipe-like femur 8) Patients with radiation osteonecrosis of acetabulum 9) Patients with systemic or local infection 10) Patients with vascular interruption in affected leg 11) Patients without the ability of walking at the postoperative time 12) Suspicious patients with metal allergy 13) Pregnant patients, pregnant suspicious patients, or patients who hope for pregnancy 14) Patients with the disease which can affect consent or evaluation of the study, including dementia, schizophrenia, depression, panic disorder, or generalized anxiety disorder 15) Patients who need to undergo the lower extremity surgery within six months after participating in the study, including total hip arthroplasty and total knee arthroplasty 16) Patients who underwent the lower extremity surgery within six months before participating in the study, including total hip arthroplasty, total knee arthroplasty, or osteotomy 17) Patients who doctors judged unsuitable for the study
Target sample size	64

Research contact person
Name of lead principal investigator	1st name Yasuharu Middle name Last name Nakashima
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Orthopaedic Surgery
Zip code	8128582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5488
Email	yasunaka@ortho.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Hamai
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Orthopaedic Surgery
Zip code	8128582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5488
Homepage URL
Email	hamachan@ortho.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Nothing in particular
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Life Science, Faculty of Life Science, Kyushu Sangyo University Department of biorobotics, faculty of engineering, Kyushu Sangyo university
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for clinical and translational research, Kyushu University
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel	092-642-5082
Email	byskenkyu@jimu.kyushu-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	九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 14 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	60
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 11 Month 14 Day
Date of IRB	2017 Year 11 Month 14 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 14 Day
Last modified on	2022 Year 03 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036222