A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery

Conditions
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Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity, Spinal Stenosis, Spinal Tumor

Intervention / Treatment
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* Device: Johnson&Johnson Medical Suzhou made Spine Fusion System
* Device: Imported EXPEDIUM screws and OPAL cage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-70 years old, male or female; 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 a local or systemic infection. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: China made spine fusion system<br>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<br>* interventional device is Spine Fusion System that is manufactured by Johnson & Johnson Medical Suzhou Ltd.<br>|
| Active Comparator: Imported spine fusion system<br>patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage . | Device: Imported EXPEDIUM screws and OPAL cage<br>* Comparator in this study is active comparator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Japanese Orthopaedic Association score | Questionnaire | Preoperation and 24week post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate of Japanese Orthopaedic Association score | Questionnaire | 7day, 12week, and 24week post operation | 
| Fixation stability | 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). | 12week, and 24week post operation | 
| Visual Analogue Score of low back and leg pain | Visual Analogue Scale | 7day, 12week, and 24week post operation | 
| Wound healing | would healing are classified as 3 classes. (Class I, Class II, Class III) | 7day, 12week, and 24week post operation |