UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044979 |
|---|---|
| Receipt number | R000051392 |
| Scientific Title | Accuracy of AR navigation for cup placement in total hip arthroplasty |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2022/08/29 17:04:02 |
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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
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
tanino@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051392
