UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015210 |
|---|---|
| Receipt number | R000017672 |
| Scientific Title | Analysis of bone metabolism on orthopedic implants by NaF PET/CT |
| Date of disclosure of the study information | 2014/09/19 |
| Last modified on | 2019/03/28 15:39:14 |
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Basic information
Public title
Analysis of bone metabolism on orthopedic implants by NaF PET/CT
Acronym
Analysis of bone metabolism on orthopedic implants by NaF PET/CT
Scientific Title
Analysis of bone metabolism on orthopedic implants by NaF PET/CT
Scientific Title:Acronym
Analysis of bone metabolism on orthopedic implants by NaF PET/CT
Region
| Japan |
Condition
Condition
Fractures, osteoarthritis, and rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the usefulness of NaF PET/CT and describe the bone metabolism around orthopedic implants including total hip arthroplaty (THA), total knee arthroplasty (TKA), pedicle screws, and spinal cages
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Computer-aided quantitative intensity of bone NaF uptake compared with healthy controls to assess response after placement of orthopedic implants including total hip arthroplaty (THA), total knee arthroplasty (TKA), pedicle screws, and spinal cages.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
NaF PET
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged >= 50 years old
2) Patients with vertebral fractures or femoral neck fracture
3) Patients undergoing total hip arthroplasty, total knee arthroplasty, or spinal surgery
4) Patient can understand and comply with the protocol and has signed the informed consent document at screening.
Key exclusion criteria
Patient considered to be inappropriate for the study by the attending doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo metropolitan geriatric hospital and institute of gerontology
Division name
Department of orthopedic surgery
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015
TEL
03-3964-1141
miyazak14@tmig.or.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Miyazaki |
Organization
Tokyo metropolitan geriatric hospital and institute of gerontology
Division name
Department of orthopedic surgery
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015
TEL
03-3964-1141
Homepage URL
miyazak14@tmig.or.jp
Sponsor or person
Institute
Tokyo metropolitan geriatric hospital and institute of gerontology
Institute
Department
Personal name
Funding Source
Organization
Tokyo metropolitan geriatric hospital and institute of gerontology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo metropolitan geriatric hospital and institute of gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015
Tel
03-3964-1141
miyazak14@tmig.or.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
| 2014 | Year | 09 | Month | 19 | 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
| 2014 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017672
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
