UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025768 |
|---|---|
| Receipt number | R000028122 |
| Scientific Title | Open-label, non-controlled study of patient specific femoral guide (PSG) for total hip arthroplasty (THA), linked with 3D surgical support software |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2017/10/06 00:31:57 |
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Basic information
Public title
Open-label, non-controlled study of patient specific femoral guide (PSG) for total hip arthroplasty (THA), linked with 3D surgical support software
Acronym
Study of PSG for THA, linked with 3D surgical support software
(Study of PSG for THA)
Scientific Title
Open-label, non-controlled study of patient specific femoral guide (PSG) for total hip arthroplasty (THA), linked with 3D surgical support software
Scientific Title:Acronym
Study of PSG for THA, linked with 3D surgical support software
(Study of PSG for THA)
Region
| Japan |
Condition
Condition
Hip joint disease scheduled for total hip arthroplasty (Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of efficacy and safety for patient specific guide, linked with 3D surgical support software on total hip arthroplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defference of stem antetorsion (by neck axis)between 3D pre-operative planning and post-operative implantation.
Key secondary outcomes
Differences between 3D pre-operative planning and post-operative implantation in the following items.
-Stem angle differences in antetorsion (by stem axis), varus / valgus, and flextion / extension.
-Depth from center of stem.
-Stem spatial position differences in x (coronal)-axis, y (sagittal)-axis, and z (
axial)-axis.
-Cup angle differences in radiographic inclination (RI) and radiographic anteversion (RA).
-Cup spatial position differences in x (coronal)-axis, y (sagittal)-axis, and z(axial)-axis.
Leg length discrepancy.
Adverse event.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using patient specific guide linked with 3D surgical support software for total hip arthroplasty
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) Age more than 20 years, at the time of acquiring consent
(2) Document consent canbe obtained by the patient's free will, after receiving sufficient explanation for the participation of this study, after understanding
Key exclusion criteria
(1) Patients judged by the principal investigator to be inappropriate as subjects
(2) Patients who have been registered in the past in this study
(3) Patients with posterior pelvic inclination more than 20 degrees
(4) Patients with or suspected to have Creutzfeldt-Jakob disease
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daihei Kida |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL
052-951-1111
kidad@nnh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daihei Kida |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL
052-951-1111
Homepage URL
kidad@nnh.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Nagoya Medical Center
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
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
独立行政法人 国立病院機構
名古屋医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 06 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 13 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2017 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028122
