UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002406 |
|---|---|
| Receipt number | R000002884 |
| Scientific Title | Clinical trial for bone union of allografts in periprosthetic femoral fracture of total hip arthroplasty by LIPUS |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2013/03/01 10:30:51 |
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Basic information
Public title
Clinical trial for bone union of allografts in periprosthetic femoral fracture of total hip arthroplasty by LIPUS
Acronym
Effect of LIPUS on allograft bone union
Scientific Title
Clinical trial for bone union of allografts in periprosthetic femoral fracture of total hip arthroplasty by LIPUS
Scientific Title:Acronym
Effect of LIPUS on allograft bone union
Region
| Japan |
Condition
Condition
periprosthetic femoral fracture of total hip arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effect of LIPUS on acceleration of bone union of grafted in periprosthetic femoral fracture of total hip arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the period of callus formation and bone union after operation by radiograph
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
Periprosthetic femoral fracture of total hip arthroplasty is treated by allograft in usual procedure. LIPUS treatment was started 4 weeks after surgery and consisted on one twenty-minute period each day for 52 weeks after surgery.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients are able to use LIPUS device properly.
(2) Patients aged between 20 and 64 years are recruited.
Key exclusion criteria
(1)The patient receiving LIPUS treatment or electrical stimulation before.
(2)The patient who is unable to apply LIPUS treatment.
(3)The patient had recent severe systemic past history such as heart, liver or kidney disease.
(4)The patient had abnormal skin sensitivity or sensory paralysis.
(5)The patient had unhealed skin injury.
(6)The patient had treated cancer therapy within recent five years.
(7)The patient is pregnant or possible pregnant.
(8)The patient who is unable to comply with this study protocol spontaneuosly.
(9)The patient who is unable to comply with the consent form of this study .
(10)The patient who was recognized unsuitable for this study by primary physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko Akiyama |
Organization
Kyoto University
Division name
Department of Orthopaedics
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University
Division name
Department of Orthopaedics
Zip code
Address
TEL
075-751-3652
Homepage URL
Sponsor or person
Institute
Department of Orthopaedics, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedics, Kyoto University
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 09 | 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
| 2009 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 31 | Day |
Last modified on
| 2013 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002884
