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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| China made spine fusion system | Experimental | patents in this arm will be implanted with Johnson&Johnson Medical Suzhou made Spine Fusion System. |
|
| Imported spine fusion system | Active Comparator | patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Johnson&Johnson Medical Suzhou made Spine Fusion System | Device | interventional device is Spine Fusion System that is manufactured by Johnson & Johnson Medical Suzhou Ltd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Japanese Orthopaedic Association score | Questionnaire | Preoperation and 24week post operation |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of events | up to 24week post operation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Tian | Beijing Jishuitan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Province Hospital | Hefei | Anhui | 230088 | China | ||
| Beijing Jishuitan Hospital |
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| Imported EXPEDIUM screws and OPAL cage | Device | Comparator in this study is active comparator. |
|
| 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 |
| Beijing |
| Beijing Municipality |
| 100035 |
| China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| Shanghai Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| Xijing Hospital | Xi’an | Shanxi | 710032 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University Medical College | Xi’an | Shanxi | 710061 | China |
| The First Affiliated Hospital of Kunming Medical College | Kunming | Yunnan | 650032 | China |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| D016103 | Spinal Fractures |
| D013130 | Spinal Stenosis |
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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