UMIN-CTR Clinical Trial

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
Last 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
Email	miyazak14@tmig.or.jp

Public contact
1st 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
Email	miyazak14@tmig.or.jp

Sponsor
Institute	Tokyo metropolitan geriatric hospital and institute of gerontology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017672