UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029344 |
|---|---|
| Receipt number | R000033536 |
| Scientific Title | Analysis of cup angle assisted by ACO guide |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2017/09/29 09:54:29 |
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Basic information
Public title
Analysis of cup angle assisted by ACO guide
Acronym
Cup angle analysis by ACO guide
Scientific Title
Analysis of cup angle assisted by ACO guide
Scientific Title:Acronym
Cup angle analysis by ACO guide
Region
| Japan |
Condition
Condition
Neck fracture, Hip OA, Hip RA, Osteonecrosis of the hip joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with femoral neck fracture or hip osteoarthritis or rheumatoid arthritis or idiopathic femoral head necrosis who will be judged to undergo total hip arthroplasty, the purpose of this study is to evaluate cup angle in 3D CT image, which was simulated preoperatively and implanted postoperatively by ACO guide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of 3 dimensional angle of implanted cup after operation immediately
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Operation support operation 1 day
Interventions/Control_2
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
Eligible patients with inclusion criteria and without exclusion criteria described as below
1) Patients with hip osteoarthritis, rheumatoid arthritis, idiopathic osteonecrosis of the femoral head, which the researcher deemed application of total hip arthroplasty, will be the target diseases in this study.
2) Patients with primary total hip arthroplasty, using cementless cup.
3) Patients over 20 years old
4) Patient who signed informed consent form with patient's own voluntary intention.
During the observation period, patients who intend to continue to participate in this study
Key exclusion criteria
Patients will be excluded as follow
1) Patients with infection
2) Patients with primary bone tumor or metastatic bone tumor who developed large bone defect to support the implant
3) Patients with surgical history such as osteotomy in the pelvis, with significant bone deformity
4) Patient who performs total hip arthroplasty in supine position
5) Patients who developed dementia and influence to obtain adequate evaluation
6) In patients with systemic disease, which affects the assessment
7) Pregnant patients, possible patients of pregnant
8) Patients whom the research director judged as noneligible
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Nagoya |
Organization
Sapporo Medical University
Division name
Dept. of Musculoskeletal Biomechanics and Surgical Development
Zip code
Address
S1 W17 Chuo-Ku, Sapporo, Japan
TEL
011-611-2111(39200)
nagoya@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukikko Yoshida |
Organization
Sapporo Medical University
Division name
Department of Orthopedic Surgery
Zip code
Address
S1 W16 Chuo-Ku, Sapporo, Japan
TEL
011-611-2111(33350)
Homepage URL
y.yoshida@sapmed.ac.jp
Sponsor or person
Institute
Dept. of Musculoskeletal Biomechanics and Surgical Development Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan MDM
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 10 | Month | 01 | 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
| 2017 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | 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
| 2017 | Year | 09 | Month | 29 | Day |
Last modified on
| 2017 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033536
