UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010625 |
|---|---|
| Receipt number | R000012424 |
| Scientific Title | The survey study of Dual-Mobility-THA for femoral neck fracture, on the indication and the efficacy/safety |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2013/06/11 14:00:44 |
* 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
The survey study of Dual-Mobility-THA for femoral neck fracture, on the indication and the efficacy/safety
Acronym
DM THA Study
Scientific Title
The survey study of Dual-Mobility-THA for femoral neck fracture, on the indication and the efficacy/safety
Scientific Title:Acronym
DM THA Study
Region
| Japan |
Condition
Condition
Femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy/ safety of Dual Mobility (DM) system. And to show the indiccation of it.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional evaluation
QOL evaluation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients have diagnosis of femoral neck fracture.
2) Patients for the indication of both of DM THA and BHA.
3) Patients are age 20 or over.
4) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form
5) Patients are willing and able to comply with postoperative scheduled evaluations
Key exclusion criteria
1) Patients have bacterial infectious disease or have risk highly of bacterial infection.
2) Patients have treatment history of acetabulum/ femur.
3) Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) > 40.
4) Patients who is pregnant female or maybe so.
5) Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6) Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy), which limits ability to evaluate the safety and efficacy of the device.
7) Patients who are immunologically suppressed or receiving chronic steroids, which limits ability to evaluate the safety and efficacy of the device.
8) Patients who are judged ineligible with reasonable reason by primary doctor.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomotaro Sato |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Orthopaedics
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya Aichi 460-0001, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 07 | 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
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Follow up: 2 years
Management information
Registered date
| 2013 | Year | 04 | Month | 30 | Day |
Last modified on
| 2013 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012424
