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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040072 |
Receipt No. | R000045663 |
Scientific Title | Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum |
Date of disclosure of the study information | 2020/05/01 |
Last modified on | 2021/04/09 |
Basic information | ||
Public title | Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum | |
Acronym | The usefulness of navigation system in TOA | |
Scientific Title | Clinical Evaluation of the usefulness of CT-based navigation system in transposition osteotomy of acetabulum | |
Scientific Title:Acronym | The usefulness of navigation system in TOA | |
Region |
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Condition | ||
Condition | Osteoarthritis secondary to hip dysplasia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to clarify the usefulness of CT-based navigation system in transposition osteotomy of acetabulum by comparing the accuracy of the osteotomy and the clinical results with those of the conventional method. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | To evaluate the difference between the preoperative planning and the actual osteotomy line. |
Key secondary outcomes | To evaluate the difference in three-dimensional acetabular coverage of the femoral head between postoperative CT and preoperative planning. To evaluate physical activity and hip function preoperatively and at 1-year postoperatively. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | transposition osteotomy of acetabulum in conventional method | |
Interventions/Control_2 | transposition osteotomy of acetabulum using CT-based navigation system | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Age: 16 to 60 years-old
2) Male and Female 3) Patients with the ability of consent and writing. If a patient is under 20 years-old, his/her patients with the ability of consent and writing. 4) Patients who can visit hospital as scheduled during the research period |
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Key exclusion criteria | 1) Patients with immature bone structure
2) Suspicious patients with metal allergy 3) Pregnant patients, pregnant suspicious patients, or patients who hope for pregnancy 4) Patients with the disease which can affect consent or evaluation of the study, including dementia, schizophrenia, depression, panic disorder, or generalized anxiety disorder 5) Patients who doctors judged unsuitable for the study |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate School of Medical Sciences, Kyushu University | ||||||
Division name | Department of Orthopaedic Surgery | ||||||
Zip code | 8128582 | ||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 0926425488 | ||||||
yasunaka@ortho.med.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Graduate School of Medical Sciences, Kyushu University | ||||||
Division name | Department of Orthopaedic Surgery | ||||||
Zip code | 8128582 | ||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 0926425488 | ||||||
Homepage URL | |||||||
goromoto@ortho.med.kyushu-u.ac.jp |
Sponsor | |
Institute | Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | JPN |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Section of IRB & Ethics Committee Administration, Academic Research Support Division, Kyushu University Hospital |
Address | 3-1-1, Maidashi, Higashi-ku |
Tel | 0926425082 |
byskenkyu@jimu.kyushu-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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045663 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |