A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
NCT ID: NCT02252185
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2014-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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China made spine fusion system
patents in this arm will be implanted with Johnson\&Johnson Medical Suzhou made Spine Fusion System.
Johnson&Johnson Medical Suzhou made Spine Fusion System
interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.
Imported spine fusion system
patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .
Imported EXPEDIUM screws and OPAL cage
Comparator in this study is active comparator.
Interventions
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Johnson&Johnson Medical Suzhou made Spine Fusion System
interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.
Imported EXPEDIUM screws and OPAL cage
Comparator in this study is active comparator.
Eligibility Criteria
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Inclusion Criteria
* Subject being diagnosed as having disc degeneration disease, spondylolisthesis, spinal fracture, deformity(degenerative deformity), spinal stenosis, or spinal tumor, has been treated with conservative treatment without relief or getting worse, who is suitable for surgery according to clinic practice.
* Subject is a suitable candidate for implanting investigational products described in study protocols according to investigator's assessment;
* Patient, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and willing to be available for each required study procedure over the study duration.
* Subject has been given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to study Sponsor.
Exclusion Criteria
* Patient has had one or more previous non-fusion spinal surgery at the involved level(s).
* Patient without spinal deformity and requires fusion at 3 or more levels.
* Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
* Has presence of active malignancy
* Has a medical condition with less than 1 year of life expectancy.
* Pregnancy or women in lactation period.
* Is grossly obese, i.e. Body Mass Index≥40.
* Has a diagnosis, which requires postoperative medication or treatment that interferes with fusion, such as steroids, chemotherapy, radiotherapy, growth factor (for more than 3 months), Nonsteroidal Antiinflammatory Drugs(for more than 3 months), and etc.
* Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. uncontrolled Diabetes with medication, renal osteodystrophy, or osteogenesis imperfect)
* Alcoholic (taking more than 40g/day, equals to 100ml 50°Chinese liquor), smoking more than 40 cigarettes/day, or Drug abuser;
* Is currently participating in another investigational drug or device study.
20 Years
70 Years
ALL
Yes
Sponsors
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Johnson & Johnson Medical (Suzhou) Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Tian
Role: PRINCIPAL_INVESTIGATOR
Beijing Jishuitan Hospital
Locations
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Anhui Province Hospital
Hefei, Anhui, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Xijing Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi’an, Shanxi, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China
Countries
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Other Identifiers
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DPS-201303
Identifier Type: -
Identifier Source: org_study_id