UMIN-CTR Clinical Trial

Basic information
Public title	A comparative study of the two types of registration methods for portable Imageless Navigation (NAVISWISS) during total hip arthroplasty in the lateral position: Registration in the supine position versus in the lateral position. A prospective randomized controlled trial
Acronym	A comparative study of the two types of registration methods for portable Imageless Navigation (NAVISWISS) during total hip arthroplasty in the lateral position: Registration in the supine position versus in the lateral position. A prospective randomized controlled trial
Scientific Title	A comparative study of the two types of registration methods for portable Imageless Navigation (NAVISWISS) during total hip arthroplasty in the lateral position: Registration in the supine position versus in the lateral position. A prospective randomized controlled trial
Scientific Title:Acronym	A comparative study of the two types of registration methods for portable Imageless Navigation (NAVISWISS) during total hip arthroplasty in the lateral position: Registration in the supine position versus in the lateral position. A prospective randomized controlled trial
Region	Japan

Condition
Condition	Hip joint disease scheduled for total hip arthroplasty Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture, rapidly destructive coxopathy, subchondral insufficiency fracture of the femoral head.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	NAVISWISS navigation system has two methods of pelvic registration during surgery. To compare the accuracy and safety of the acetabular cup placement during total hip arthroplasty between these methods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The absolute values of the differences between cup inclination and anteversion angles displayed on the navigation screen and angles measured on the radiograph immediately after surgery and computed tomography 1 month after surgery.
Key secondary outcomes	Any intraoperative and postoperative complications (dislocation, infection, malfunction of navigation during surgery, loosening of pins, etc.)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Total hip arthroplasty performed with portable imageless navigation system (NAVISWISS). Pelvic registration is performed in the supine position, followed by surgery in the lateral decubitus position.
Interventions/Control_2	Total hip arthroplasty performed with portable imageless navigation system (NAVISWISS). Pelvic registration is performed in the lateral decubitus position, and surgery is performed in the lateral decubitus position.
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	Patients scheduled for total hip arthroplasty
Key exclusion criteria	Patients scheduled for revision total hip arthroplasty. Patients scheduled for total hip arthroplasty with shortening subtrochanteric osteotomy. Patients with extreme pelvic deformity
Target sample size	100

Research contact person
Name of lead principal investigator	1st name hiroyuki Middle name Last name ogawa
Organization	Hokusuikai Kinen Hospital
Division name	Orthopaedic surgery
Zip code	310-0035
Address	3-2-1 Higashihara, Mito, Ibaraki, Japan
TEL	0293033003
Email	wscww899@yahoo.co.jp

Public contact
Name of contact person	1st name hiroyuki Middle name Last name ogawa
Organization	Hokusuikai Kinen Hospital
Division name	Orthopaedic surgery
Zip code	310-0035
Address	3-2-1 Higashihara, Mito, Ibaraki, Japan
TEL	0293033003
Homepage URL
Email	wscww899@yahoo.co.jp

Sponsor
Institute	Hokusuikai Kinen Hospital
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)

IRB Contact (For public release)
Organization	Hokusuikai Kinen Hospital
Address	3-2-1 Higashihara, Mito, Ibaraki, Japan
Tel	0293033003
Email	hakoda@hokusuikai-kinen.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	2022 Year 02 Month 08 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	Preinitiation
Date of protocol fixation	2021 Year 12 Month 15 Day
Date of IRB	2022 Year 12 Month 21 Day
Anticipated trial start date	2022 Year 02 Month 08 Day
Last follow-up date	2024 Year 02 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 02 Month 07 Day
Last modified on	2022 Year 02 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053451