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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031726
Receipt No. R000036222
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
Date of disclosure of the study information 2018/03/14
Last modified on 2018/03/14

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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
Middle name
Last name Yasuharu Nakashima
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Orthopaedic Surgery
Zip code
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
Middle name
Last name Satoshi Hamai
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Orthopaedic Surgery
Zip code
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
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 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
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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
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
2018 Year 03 Month 14 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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