UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006112 |
|---|---|
| Receipt number | R000007230 |
| Scientific Title | The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2015/02/03 09:12:59 |
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Basic information
Public title
The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface
Acronym
The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface
Scientific Title
The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface
Scientific Title:Acronym
The exploratory study of external fixation screws for improving their fixation strength in bone-screw interface
Region
| Japan |
Condition
Condition
Disease around the wrist
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of the external fixation screws with a calcium phosphate coating containing fibroblast growth factor (FGF-2) (coating screws) for disease around the wrist
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety assessment of the coating screws: evaluation of the incidence of adverse events including secondary fracture, severe pin-tract infection
Key secondary outcomes
Assessment either fixation strength of the coating screws or pin-tract infection.
1)Macroscopic findings of pin-tract infection (grading according to the Checketts & Otterburn classification)
2)Bacterial inspection surrounding the coating screws
3)Evaluation of bone surrounding the coating screws using X-ray and CT scanning
4)Inspection of surfaces of extracted coating screw using a microscope
5)Measurement of pain caused by extraction of the coating screws (according to the visual analog scale (VAS))
6)Measurement of fixation strength in bone-screw interface (insertion and extraction torque)
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
Coating screws prepared only using clinically approved materials are percutaneously implanted in patients to whom external fixator should be applied for disease around the wrist
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with disease around the wrist to whom monolateral external fixator should be applied.
2)Between 20 to 75 years of age
Key exclusion criteria
1)Dermatological disease
2)Severe complication (including cardiac, liver and renal diseases)
3)History of malignancy in the last 5 years from the consent date for this study, or suspicion of malignancy
4)Pregnant or possibly pregnant women
5)Incapableness of consent due to cognitive problem
6)Incapableness of consent in writing
7)Any other reasons when the doctor-in-charge considered to be unsuitable in this study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Yamazaki |
Organization
University of Tsukuba
Division name
Orthopaedic Surgery
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3219
masashiy@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Mutsuzaki |
Organization
Ibaraki Prefectural University of Health Sciences Hospital
Division name
Orthopaedic Surgery
Zip code
Address
4733, Ami, Ami, Inashiki, Ibaraki
TEL
029-888-9200
Homepage URL
mutsuzaki@ipu.ac.jp
Sponsor or person
Institute
Orthopaedic Surgery, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Orthopaedic Surgery, University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Advanced Industrial Science and Technology
Ibaraki Prefectural University of Health Sciences
Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL)
Name of secondary funder(s)
National Institute of Advanced Industrial Science and Technology
Ibaraki Prefectural University of Health Sciences
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2011 | Year | 08 | Month | 03 | Day |
Last modified on
| 2015 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007230
