UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046854 |
|---|---|
| Receipt number | R000053451 |
| 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 |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2022/02/07 20:02:29 |
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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
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
wscww899@yahoo.co.jp
Sponsor or person
Institute
Hokusuikai Kinen Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053451
