UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051818 |
|---|---|
| Receipt number | R000059106 |
| Scientific Title | Prospective multi-center postoperative outcomes cohort study in femoral trochanteric fractures |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/04/25 09:09:10 |
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Basic information
Public title
Prospective multi-center postoperative outcomes cohort study in femoral trochanteric fractures
Acronym
Prospective CMF Study
Scientific Title
Prospective multi-center postoperative outcomes cohort study in femoral trochanteric fractures
Scientific Title:Acronym
Prospective CMF Study
Region
| Japan |
Condition
Condition
Femoral trochanteric fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the postoperative and radiographic outcomes in osteosynthesis with ZNN CM Fortis Nail for femoral trochanteric fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment success rate 6 months after surgery
Key secondary outcomes
The incidence of oversliding, The incidence rate of postoperative complications, The maintenance rate of walking ability related to patient QOL
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Primary closed femur trochanteric fracture.
2. 20 years and over.
3. Patients who have gave appropriate consent using an IRB/EC approved document.
Key exclusion criteria
1. Unable to walk on their own before injury
2. When additional procedures (cables, plates, etc.) are required in addition to intramedullary nail
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hisayoshi |
| Middle name | |
| Last name | Inoue |
Organization
Sendai Tokushukai Hospital
Division name
Orthopedic
Zip code
981-3116
Address
9-8 Takatamacho Sendai Izumi-ku, Miyagi, 981-3116, Japan
TEL
022-771-5111
hi-inoue@tohokuh.johas.go.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Shiraishi |
Organization
ZimmerBiomert G.K.
Division name
Clinical Affairs
Zip code
105-0011
Address
11-1 Shibakoen 2-chome, Minato-ku, Tokyo 105-0011, Japan
TEL
090-6182-0364
Homepage URL
yukako.shiraishi@zimmerbiomet.com
Sponsor or person
Institute
Sendai 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
The Tokushukai Group Ethics Committee
Address
Tokyodouchiyoda build 15F, 1-3-1 kudanminami, Chiyoda-ku, Tokyo Japan
Tel
03-3263-4801
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
| 2023 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship between primary/secondary outcomes and following variables will be evaluated (multivariate analysis and/or subgroup analysis).
- The position of distal screw
- The number of distal screw
- Nail diameter
- Fracture classification
- Dislocation classification
- AS2 insertion error
- Radiographic evaluation/measurement results
Management information
Registered date
| 2023 | Year | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059106
