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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 | UMIN000031602 |
Receipt No. | R000035942 |
Scientific Title | A pilot study of a simple navigation system for Total Hip Arthroplasty in the lateral position using augmented reality technology |
Date of disclosure of the study information | 2018/03/06 |
Last modified on | 2018/03/06 |
Basic information | ||
Public title | A pilot study of a simple navigation system for Total Hip Arthroplasty in the
lateral position using augmented reality technology |
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Acronym | A pilot study of a simple navigation system for Total Hip Arthroplasty in the
lateral position using augmented reality technology |
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Scientific Title | A pilot study of a simple navigation system for Total Hip Arthroplasty in the
lateral position using augmented reality technology |
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Scientific Title:Acronym | A pilot study of a simple navigation system for Total Hip Arthroplasty in the
lateral position using augmented reality technology |
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Region |
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Condition | ||
Condition | Hip joint disease scheduled for total hip arthroplasty
Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture, rapidly destructive coxopathy, subchondral insufficiency fracture of the femoral head. |
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Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the effecacy and safety of THA using a simple navigation system using AR technology for patients scheduled THA in the lateral position |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The Accuracy of Implant Placement using X-ray and CT at 3 months postoperative (Absolute value error between intraoperative measured value and postoperative measured value) |
Key secondary outcomes | Using CT at 3 months after surgery,
-Cup installation angle and differences from 3-dimensional preoperative plan (adiographic inclination (RI) and radiographic anteversion (RA)) -Accuracy of leg extension and femoral neck cut level(Absolute value error between intraoperative measured value and postoperative measured value) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Pseudo-randomization |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Set the target angle in advance, and install the cup using (A)angle goniometer. After installing the cup, Measure installation angle by using (B)simple navigation system using AR technology | |
Interventions/Control_2 | Set the target angle in advance, and install the cup using (A)simple navigation system using AR technology. After installing the cup, Measure installation angle by using (B)angle goniometer. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) Patients who are scheduled to undergo THA with hip joint disease.
(2) Patients aged 20 years or older at the time of acquiring consent (4) Document consent can be obtained by the patient's free will, after receiving sufficient explanation for the participation of this study, after understanding |
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Key exclusion criteria | (1) Patients who have been registered in the past in this study
(2) Patients judged by the principal investigator to be inappropriate as subjects |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nissan Tamagawa Hospital | ||||||
Division name | Department of Orthopaedic Surgery | ||||||
Zip code | |||||||
Address | 4-8-1 Seta, Setagaya, Tokyo | ||||||
TEL | 03-3700-1151 | ||||||
wscww899@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nissan Tamagawa Hospital | ||||||
Division name | Department of Orthopaedic Surgery | ||||||
Zip code | |||||||
Address | 4-8-1 Seta, Setagaya, Tokyo | ||||||
TEL | 03-3700-1151 | ||||||
Homepage URL | |||||||
wscww899@yahoo.co.jp |
Sponsor | |
Institute | Nissan Tamagawa Hospital |
Institute | |
Department |
Funding Source | |
Organization | Nissan Tamagawa Hospital |
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 | |
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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 | |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information |
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=R000035942 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |