A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery
1 other identifier
interventional
106
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
September 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 3, 2015
March 1, 2015
1.2 years
September 24, 2014
December 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Japanese Orthopaedic Association score
Questionnaire
Preoperation and 24week post operation
Secondary Outcomes (4)
Improvement rate of Japanese Orthopaedic Association score
7day, 12week, and 24week post operation
Fixation stability
12week, and 24week post operation
Visual Analogue Score of low back and leg pain
7day, 12week, and 24week post operation
Wound healing
7day, 12week, and 24week post operation
Other Outcomes (1)
Adverse Events
up to 24week post operation
Study Arms (2)
China made spine fusion system
EXPERIMENTALpatents in this arm will be implanted with Johnson\&Johnson Medical Suzhou made Spine Fusion System.
Imported spine fusion system
ACTIVE COMPARATORpatents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .
Interventions
interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.
Comparator in this study is active comparator.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Anhui Province Hospital
Hefei, Anhui, 230088, China
Beijing Jishuitan Hospital
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Tian
Beijing Jishuitan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2014
First Posted
September 30, 2014
Study Start
July 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
December 3, 2015
Record last verified: 2015-03