Viper Prime(R) spine system Japan Study

Not Applicable

• Conditions: spinal degenerative disease, spinal tumors, or vertebral fracture.

• Registration Number: JPRN-jRCTs032190039
• Lead Sponsor: Ohmori Kazuo

Brief Summary

As a Primary endpoint, the accuracy rate was 85.7% in VP arm and 75.0%. The difference in accuracy rate between arms was 10.7%, thus proving the non-inferiority of VP arm to CD arm. As a secondary endpoint, VP arm was significant different from CD arm in screw insertion time and in the number of fluoroscopes associated with screw insertion time. As a Safety Endpoint, no adverse events were reported in relation to the study products or the study treatment. No new safety concerns of note were identified.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Study Completion: 2020-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
-Diseases, disabilities/deaths, and infections that are suspected to be related to this trial will be assessed. <br>-The screw insertion time during screw insertion.<br>-The number of fluoroscopic observations during screw insertion.