![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041847 |
Receipt No. | R000047771 |
Scientific Title | Intervention study for the accuracy of the cup positioning in total hip arthroplasty with the patient specific guide made by Zed HIP 3D planning software on CT based images |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2020/09/19 |
Basic information | ||
Public title | The accuracy of the cup positioning in total hip arthroplasty with the patient specific guide made by 3D planning software on CT based images | |
Acronym | The accuracy of the cup positioning in total hip arthroplasty with the patients specific guide | |
Scientific Title | Intervention study for the accuracy of the cup positioning in total hip arthroplasty with the patient specific guide made by Zed HIP 3D planning software on CT based images | |
Scientific Title:Acronym | Intervention study for the accuracy of the cup positioning with the patient specific guide | |
Region |
|
Condition | ||
Condition | osteoarthritis of the hip | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the accuracy of the cup positioning in total hip arthroplasty with the patient specific guide made by Zed HIP 3D planning software on CT based images |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The postoperative insertion angles of the cups |
Key secondary outcomes | Dislocation rate |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | the accuracy of the cup positioning in total hip arthroplasty (THA) with the patient specific guide made by Zed HIP 3D planning software on CT based images (40 hips) | |
Interventions/Control_2 | the accuracy of the cup positioning in THA with the computer navigation technique on CT based images (40 hips) | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1. secondary osteoarthritis due to femoral neck fracture, developmental dysplasia of the hip, rheumatoid arthritis and osteonecrosis of the femoral head
2. primary THA 3. in case of patients more than 20 years old 4. in case of patients who can voluntarily signed the agreement form 5. in case of patients who can continually receive a medical examination |
|||
Key exclusion criteria | 1. In case of patients with a high risk of developing bacterial and fungal infections
2. In case of patients without the thickness of a bone sufficient for placing the implant 3. In case of patients with excessive deformation of the femoral bone 4. In case of patients who is suffering from dementia and cannot be evaluated by questionnaire. 5. In case of patients who is or may be pregnant |
|||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Ehime University | ||||||
Division name | Department of Bone and Joint Surgery | ||||||
Zip code | 791-0295 | ||||||
Address | Shitsukawa, Toon, Ehime, Japan | ||||||
TEL | 0899605343 | ||||||
hiroimai@m.ehime-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Ehime University Graduate School of Medicine | ||||||
Division name | Department of Bone and Joint Surgery | ||||||
Zip code | 791-0295 | ||||||
Address | Shitsukawa, Toon, Ehime, Japan | ||||||
TEL | 0899605343 | ||||||
Homepage URL | |||||||
hiroimai@m.ehime-u.ac.jp |
Sponsor | |
Institute | Department of Bone and Joint Surgery
Ehime University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Department of Bone and Joint Surgery
Ehime University Graduate School of Medicine |
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 | Ehime University Graduate School of Medicine |
Address | Shitsukawa, Toon, Ehime, 791-0295 Japan |
Tel | 0899605343 |
orthop@m.ehime-u.ac.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 | 愛媛大学医学部付属病院(愛媛県) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 | Preinitiation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047771 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |