UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018307 |
|---|---|
| Receipt number | R000021145 |
| Scientific Title | Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures |
| Date of disclosure of the study information | 2015/07/29 |
| Last modified on | 2021/07/08 11:47:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Acronym
Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Scientific Title
Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Scientific Title:Acronym
Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Region
| Japan |
Condition
Condition
Femoral Trochanteric Fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the femoral head rotational stability of integrated lag screw compared with single lag screw design of short femoral nail in femoral trochanteric fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rotational angle of femoral head using computer tomography reconstruction images at 3-months post-op.
Key secondary outcomes
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 |
Interventions/Control_1
Short Femoral Nail with an Intergrated Lag Screw
Interventions/Control_2
Short Femoral Nail with a Single Lag Screw
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
1. Patient with femoral trochanteric fracuture, (candidate for short femoral nail fixation)
2. AO classification A1 and A2
3. Patient whose written consent was obtained to participate in the study
Key exclusion criteria
1. Adolescent who need a informed assent
2. A patient who may present difficulties of CT analysis due to metal artifacts by metal implantation at proximal femur or other factors
3. Patient ruled unfit to the study by a surgeon
Target sample size
316
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Kochi Medical Center
Division name
Department of Orthopaedics
Zip code
7218511
Address
2125-1,Ike, Kochi-shi, Kochi-ken, Japan
TEL
088-837-3000
wohltunimuri@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Tamura |
Organization
Kochi Medical Center
Division name
Department of Orthopaedics
Zip code
7218511
Address
Department of Orthopaedics
TEL
088-837-3000
Homepage URL
tamuryu_integra_type_r@yahoo.co.jp
Sponsor or person
Institute
Kochi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Smith & Nephew Orthopaedics KK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagawa Prefectural Central Hospital, Shikoku Medical Center for Children and Adults, Uwajima City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Health Sciences Center
Address
2125-1 Ike Kochi City Kochi Pref. Japan
Tel
088-837-3682
rinsyo@khsc.or.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
| 2015 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
https://www2.khsc.or.jp/info/dtl.php?ID=1110
Publication of results
Unpublished
Result
URL related to results and publications
https://www2.khsc.or.jp/info/dtl.php?ID=1110
Number of participants that the trial has enrolled
195
Results
Rotation angle was measured clinically from 0 to 8.1 degree. Dual screw type of implant is recommended to persist rotation of the proximal fragment and center Position of implant is the most important factor to prevent rotation.
Results date posted
| 2020 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Group Dual Single
N 103 92
Age 86.2 84.7
Sex Male 23 21
Female 80 71
AO classification A1 40 36
A2 63 56
CT classification stable 40 35
unstable 63 57
Participant flow
Assessed for eligibility (n=263)
Excluded (n=68)
Not Meeting incrusion criteria(n=58)
Declined to participate (n=8)
Other reasons, dupliaction (n=2)
Randomized (n=195)
Allocated to Intervention
Dual screw (n=103)
Lost to follow up (n=16)
Analysed (n=87)
Allocated to Intervention
Single screw (n=92)
Lost to follow up (n=18)
Analysed (n=74)
Adverse events
There was no complication aboue insertion od PLLA pin.One cut out case was seen in single screw grpou and revision surgery was needed.
Outcome measures
Primary outcome was rotational angle of proximal fragment and its difference between two group and primary end point was occurrence of cutout. Key secondary outcomes were comparison of rotation angle between AO classification A1 or A2, preoperative 3DCT classification, position of implant whether center or decenter, right side of left and amount of the telescoping between two groups. We used IBM SPSS version 19 for statistical Evaluation, and Unpaired t-test and Pearson's correlation coefficient as statistical method.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 12 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 14 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021145
