UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043929 |
|---|---|
| Receipt number | R000050163 |
| Scientific Title | Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2021/04/16 20:03:03 |
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Basic information
Public title
Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Acronym
Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Scientific Title
Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Scientific Title:Acronym
Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Region
| Japan |
Condition
Condition
patients of femoral intertrochanteric fracture
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of cement augmentation on early postoperative ADL scores in patients with trochanteric fractures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulated Ambulation Score(CAS) at postoperative days 1, 2, 3
Key secondary outcomes
Barthel index at post-op 1 week, walking ability (wheelchair, parallel bars, walker, cane, walking alone)
CAS at postoperative days 5
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
open reduction with cement augmentation
Interventions/Control_2
open reduction without cement augmentation
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
trochanteric fractures for the first time (Fracture type: AO/OTA classification 31A), age 60 years old above who able to walk independently before the injury (walking with a walker or higher, wheelchairs are excluded)
Key exclusion criteria
pathological fractures, open fractures, history of allergy to cement, multiple lower extremity trauma, postoperative non weight bearing, postoperative medical complications that make it difficult to leave the bed (pneumonia, heart failure, etc.)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Mochizuki |
Organization
Kaneda Hospital
Division name
orthopedics
Zip code
719-3193
Address
63, Nishihara, Maniwa city, Okayama
TEL
0867521191
catchernine4949@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Mochizuki |
Organization
Kaneda Hospital
Division name
orthopedics
Zip code
719-3193
Address
63, Nishihara, Maniwa city, Okayama
TEL
0867521191
Homepage URL
catchernine4949@yahoo.co.jp
Sponsor or person
Institute
Kaneda Hospital
Institute
Department
Personal name
Funding Source
Organization
Kaneda Hospital
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
Kaneda Hospital
Address
63, Nishihara, Maniwa city, Okayama
Tel
0867521191
catchernine4949@yahoo.co.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
| 2021 | Year | 04 | Month | 15 | 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
| 2021 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050163
