JRCT ID: jRCTs032190039
Registered date:17/06/2019
Viper Prime(R) spine system Japan Study
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | spinal degenerative disease, spinal tumors, or vertebral fracture. |
Date of first enrollment | 20/06/2019 |
Target sample size | 80 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | VIPER PRIME System Group The surgery for this group will be performed according to the operation manual of the VIPER PRIME System, as described below. Operation Procedure for the VIPER PRIME System 1. Make a skin incision. 2. Insert the screw-loaded Inserter through the incision and dock the stylet tip on an entry point at an appropriate position. 3. Extend the Stylet into the pedicle. 4. Advance the screw into the pedicle. 5. Remove the Inserter and Stylet. Control Device Group The surgery for this group will be performed according to the operation manual of each spinal fixation system, as described below. Operation Procedure for the Control Device 1. Make a skin incision. 2. Insert the needle or probe through the incision and advance it to the pedicle. 3. If the needle or probe enters into the centrum, remove the inner needle and then insert the guidewire into the centrum. 4. Remove the needle or probe. 5. Insert the tap along the guidewire. 6. Remove the tap. 7. Insert the screw. 8. Remove the guidewire. 9. Remove the driver from the screw. |
Outcome(s)
Primary Outcome | To demonstrate the non-inferiority of the VIPER PRIME System to conventional Percutaneous pedicle screw systems (control) with respect to the accuracy of pedicle screw placement determined using postoperative CT images. |
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Secondary Outcome | -Diseases, disabilities/deaths, and infections that are suspected to be related to this trial will be assessed. -The screw insertion time during screw insertion. -The number of fluoroscopic observations during screw insertion. |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | A) A male or female individual aged =>20 years. B) A patient with a diagnosis of a spinal degenerative disease (e.g., degenerative disc disease, lumbar spinal stenosis, spondylolisthesis, or scoliosis), spinal tumors, or vertebral fracture. C) A patient who are considered suitable for first instrumentation lumbosacral surgery with percutaneous pedicle screw and undergoing an instrumentation lumbosacral surgery involving at least one intervertebral segment, regardless of whether interbody fusion (e.g., MIS-TLIF, PLIF, LLIF or XLIF(R), or OLIF/ATP) is intended or not. D) A patient who voluntarily participates in this trial and signed the informed consent form stating that patient information obtained from the trial can be provided to the investigator. E) A patient who, in the opinion of the investigator or a subinvestigator, understands the purpose of the clinical trial and has the intention and abilities to comply with the procedures of the surgery and the clinical trial. F) A patient who can read and understand the Japanese informed consent form. |
Exclude criteria | A) A pregnant or breastfeeding woman. B) A patient who is undergoing a repeat surgery of the lumbar spine. C) A patient with prior pedicle screw placement into the lumbar spine. D) A patient with severe osteoporosis. E) A patient with severe spinal deformity due to scoliosis. F) A patient for whom a CT examination shows target pedicles are extremely narrow or there is a severe osteosclerotic change in a target pedicle. G) A patient who is a drug or alcohol abuser (in the past 5 years) or who has a psychiatric disorder and, in the opinion of the investigator or a subinvestigator, may be unable to comply with the study requirements defined in the protocol. |
Related Information
Primary Sponsor | Ohmori Kazuo |
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Secondary Sponsor | |
Source(s) of Monetary Support | Johnson & Johnson K.K. Medical Company |
Secondary ID(s) | Nil known |
Contact
Public contact | |
Name | Kazuo Ohmori |
Address | 1-2-1, Koukandori, Kawasaki-ku, Kawasaki City, Kanagawa 210-0852, Japan Kanagawa Japan 210-0852 |
Telephone | +81-44-333-5591 |
kazuospine@gmail.com | |
Affiliation | Nippon Koukan Hospital |
Scientific contact | |
Name | Kazuo Ohmori |
Address | 1-2-1, Koukandori, Kawasaki-ku, Kawasaki City, Kanagawa 210-0852, Japan Kanagawa Japan 210-0852 |
Telephone | +81-44-333-5591 |
kazuospine@gmail.com | |
Affiliation | Nippon Koukan Hospital |