A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
Study Details
Study Description
Brief Summary
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is a prospective, multicenter, randomized, comparative, non-inferiority study comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative 24 weeks for patients implanted with local made Spine Fusion System versus imported products.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: China made spine fusion system patents in this arm will be implanted with Johnson&Johnson Medical Suzhou made Spine Fusion System. |
Device: Johnson&Johnson Medical Suzhou made Spine Fusion System
interventional device is Spine Fusion System that is manufactured by Johnson & Johnson Medical Suzhou Ltd.
|
| Active Comparator: Imported spine fusion system patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage . |
Device: Imported EXPEDIUM screws and OPAL cage
Comparator in this study is active comparator.
|
Outcome Measures
Primary Outcome Measures
- Change of Japanese Orthopaedic Association score [Preoperation and 24week post operation]
Questionnaire
Secondary Outcome Measures
- Improvement rate of Japanese Orthopaedic Association score [7day, 12week, and 24week post operation]
Questionnaire
- Fixation stability [12week, and 24week post operation]
Fixation stability should be measured based on translational motion and angular motion which is demonstrated on X-Ray examination (A/P lateral, Flexion and extension).
- Visual Analogue Score of low back and leg pain [7day, 12week, and 24week post operation]
Visual Analogue Scale
- Wound healing [7day, 12week, and 24week post operation]
would healing are classified as 3 classes. (Class I, Class II, Class III)
Other Outcome Measures
- Adverse Events [up to 24week post operation]
Number of events
Eligibility Criteria
Criteria
Inclusion Criteria:
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20-70 years old, male or female;
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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.
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Subject is a suitable candidate for implanting investigational products described in study protocols according to investigator's assessment;
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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.
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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:
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Patient has a local or systemic infection.
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Patient has had one or more previous non-fusion spinal surgery at the involved level(s).
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Patient without spinal deformity and requires fusion at 3 or more levels.
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Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
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Has presence of active malignancy
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Has a medical condition with less than 1 year of life expectancy.
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Pregnancy or women in lactation period.
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Is grossly obese, i.e. Body Mass Index≥40.
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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.
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Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. uncontrolled Diabetes with medication, renal osteodystrophy, or osteogenesis imperfect)
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Alcoholic (taking more than 40g/day, equals to 100ml 50°Chinese liquor), smoking more than 40 cigarettes/day, or Drug abuser;
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Is currently participating in another investigational drug or device study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anhui Province Hospital | Hefei | Anhui | China | 230088 |
| 2 | Beijing Jishuitan Hospital | Beijing | Beijing | China | 100035 |
| 3 | Henan Provincial People's Hospital | Zhengzhou | Henan | China | 450003 |
| 4 | Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | China | 330006 |
| 5 | Shanghai Ruijin Hospital | Shanghai | Shanghai | China | 200025 |
| 6 | Xijing Hospital | Xi'an | Shanxi | China | 710032 |
| 7 | The First Affiliated Hospital of Xi'an Jiaotong University Medical College | Xi'an | Shanxi | China | 710061 |
| 8 | The First Affiliated Hospital of Kunming Medical College | Kunming | Yunnan | China | 650032 |
Sponsors and Collaborators
- Johnson & Johnson Medical (Suzhou) Ltd.
Investigators
- Principal Investigator: Wei Tian, Beijing Jishuitan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DPS-201303