UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017542 |
|---|---|
| Receipt number | R000020336 |
| Scientific Title | Comparison of methods for the treatment of metatarsal stress fracture |
| Date of disclosure of the study information | 2015/05/13 |
| Last modified on | 2015/05/13 17:09:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of methods for the treatment of metatarsal stress fracture
Acronym
metatarsall stress fr
Scientific Title
Comparison of methods for the treatment of metatarsal stress fracture
Scientific Title:Acronym
metatarsall stress fr
Region
| Europe |
Condition
Condition
Metatarsal stress fracture.
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare methods of conservative treatment of metatarsal stress fracture of young athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verify more effective method of treatment of metatarsal stress fracture.
Key secondary outcomes
Base
Study type
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
conservative treatment no1
Interventions/Control_2
conservative treatment no2
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Metatarsall stress fracture.
Key exclusion criteria
Traumatic metatarsal fracture.
Pathological metatarsall fracture.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maciej Karaczun |
Organization
Pomeranian Medical University in Szczecin, Poland
Division name
Chair and Clinic of Orthopaedic, Traumatology and Oncology
Zip code
Address
Unii Lubelskiej 1, 71-252, Szczecin-Poland
TEL
+48602775701
karaczun@orthomail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maciej Karaczun |
Organization
Pomeranian Medical University in Szczecin, Poland
Division name
Chair and Clinic of Orthopaedic, Traumatology and Oncology
Zip code
Address
Klonowica 27/9, 71-247, Szczecin-Poland
TEL
+48602775701
Homepage URL
karaczun@orthomail.com
Sponsor or person
Institute
Pomeranian Medical University in Szczecin
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 05 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020336
