UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042993 |
|---|---|
| Receipt number | R000048234 |
| Scientific Title | Cement augmentation in fixation of intertrochanteric fracture: a randomized controlled study |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2024/01/16 17:50:27 |
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Basic information
Public title
Cement augmentation in fixation of intertrochanteric fracture: a randomized controlled study
Acronym
Cement augmentation in fixation of intertrochanteric fracture: a randomized controlled study
Scientific Title
Cement augmentation in fixation of intertrochanteric fracture: a randomized controlled study
Scientific Title:Acronym
Cement augmentation in fixation of intertrochanteric fracture: a randomized controlled study
Region
| Japan |
Condition
Condition
intertrochanteric femur fracture in the elderly
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
TFN-ADVANCED Proximal Femoral Nailing System (TFNA)(Depuy Synthes)is an implant used for fixation of the intertrochanteric fracture, and cement augmentation is available with a fenestrated lag blade/screw. The aim of this study is to evaluate the influence of cement augmentation on the rigidity of fixation by a randomized controlled study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the amount of sliding of the lag screw until the bone union is obtained
Key secondary outcomes
Cumulated ambulance score(CAS), Functional independence measure(FIM), Visual analog scale(VAS) is obtained immediately before the injury, discharge, and after half a year from an operation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment | Maneuver |
Interventions/Control_1
cement augmentation(+)45cases
Interventions/Control_2
cement augmentation(-) 50cases
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
1. Displaced traumatic intertrochanteric femur fracture (A1 A2 and A3 AO/OTA) where a decision has been made for surgical management using a femoral nail.
2. Patients aged over 60 years.
3. Presentation to the hospital within 14 days of the injury.
4. Patients where consent is obtained.
Key exclusion criteria
1. Patients with concomitant injuries affecting the treatment and rehabilitation of the affected limb.
2. Patients with associated neurovascular injuries requiring immediate surgery.
3. Open fracture.
4. Patients whose bone quality is obviously good.
5. Patients who have any other reason for inclusion in the study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Sengoku |
Organization
Ogaki Tokushukai Hospital
Division name
orthopedics
Zip code
5030015
Address
6-85-1, Hayashi-machi, Ogaki city, Gifu prefecture
TEL
0584776110
sengoku.m.14@gmail.com
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Sengoku |
Organization
Ogaki Tokushukai Hospital
Division name
orthopedics
Zip code
5030015
Address
6-85-1, Hayashi-machi, Ogaki city, Gifu prefecture
TEL
0584776110
Homepage URL
sengoku.m.14@gmail.com
Sponsor or person
Institute
Ogaki Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokushukai Group Institutional Review Board
Address
Emina building 3rd floor, 1-6-7 kouji-machi, chiyoda ward, Tokyo
Tel
0332634801
mirai-ec1@mirai-iryo.com
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 | 02 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 07 | 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 | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048234
