UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032688 |
|---|---|
| Receipt number | R000037262 |
| Scientific Title | A comparison of short-term outcomes between SuperPath approach and modified transgluteal approach for bipolar hip arthroplasty |
| Date of disclosure of the study information | 2018/05/23 |
| Last modified on | 2018/05/23 17:19:36 |
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Basic information
Public title
A comparison of short-term outcomes between SuperPath approach and modified transgluteal approach for bipolar hip arthroplasty
Acronym
A comparison of short-term outcomes between SuperPath approach and modified transgluteal approach for bipolar hip arthroplasty
Scientific Title
A comparison of short-term outcomes between SuperPath approach and modified transgluteal approach for bipolar hip arthroplasty
Scientific Title:Acronym
A comparison of short-term outcomes between SuperPath approach and modified transgluteal approach for bipolar hip arthroplasty
Region
| Japan |
Condition
Condition
Femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparison of short-term outcomes between SuperPath approach and modified transgluteal approach for bipolar hip arthroplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The outcome measures included the operative time, intraoperative blood loss, depth of implant subsidence at 1 month postoperatively, number of days to start walking, and intraoperative and postoperative complications. Comparisons were made using the unpaired t-test for the operative time, intraoperative blood loss, depth of implant subsidence 1 month postoperatively, and number of days to start walking, and the chi-square test for intraoperative and postoperative complications. Differences were considered significant when p<0.05. The depth of implant subsidence was measured distance from top of greater trochanter to upper edge of stem on frontal radiographs at both immediately after the operation and 1month postoperatively. The distance was corrected on the frontal radiographs for diameter of outer head actually used.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who underwent bipolar hip arthroplasty for femoral neck or head fractures between December 2013 and November 2017 were included in this study. We used the Dall approach between December 2013 and July 2016 and switched to the SuperPath approach in August 2016.
Key exclusion criteria
Key exclusion criteria none
Target sample size
73
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Fukushima |
Organization
Fukushima Surgery
Division name
orthopedic
Zip code
Address
6430 Tohoku cho Miyakonojo Miyazaki ken Japan
TEL
+81-986-38-1633
jfk-fuku@sea.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Fukushima |
Organization
Fukushima Surgery
Division name
orthopedic
Zip code
Address
6430 Tohoku cho Miyakonojo Miyazaki ken Japan
TEL
+81-986-38-1633
Homepage URL
jfk-fuku@sea.plala.or.jp
Sponsor or person
Institute
Tachibana Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2018 | Year | 05 | Month | 23 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects who underwent bipolar hip arthroplasty for femoral neck or head fractures between December 2013 and November 2017 were included in this study. We used the Dall approach between December 2013 and July 2016 and switched to the SuperPath approach in August 2016. The SuperPath approach was used in 42 cases, while the Dall approach was used in 32 cases.
Management information
Registered date
| 2018 | Year | 05 | Month | 23 | Day |
Last modified on
| 2018 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037262
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
