Status:
COMPLETED
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
Lead Sponsor:
Johnson & Johnson Medical (Suzhou) Ltd.
Conditions:
Disc Degenerative Disease
Spondylolisthesis
Eligibility:
All Genders
20-70 years
Phase:
NA
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.
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02252185
Start Date
July 1 2014
End Date
December 1 2015
Last Update
December 3 2015
Active Locations (8)
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1
Anhui Province Hospital
Hefei, Anhui, China, 230088
2
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China, 100035
3
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
4
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006