Clinical trial NCT02252185: A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
Official title: A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disc Degenerative Disease
Spondylolisthesis
Spinal Fracture
Spinal Deformity
Spinal Stenosis
Spinal Tumor
Lead sponsor: Johnson & Johnson Medical (Suzhou) Ltd.
Sponsor class: INDUSTRY
First posted: 2014-09-30
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 patients implanted with local made Spine Fusion System versus imported products.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Japanese Orthopaedic Association score
timeFrame: Preoperation and 24week post operation
Secondary outcomes:
measure: Improvement rate of Japanese Orthopaedic Association score
timeFrame: 7day, 12week, and 24week post operation
measure: Fixation stability
timeFrame: 12week, and 24week post operation
measure: Visual Analogue Score of low back and leg pain
timeFrame: 7day, 12week, and 24week post operation
measure: Wound healing
timeFrame: 7day, 12week, and 24week post operation
Other outcomes:
measure: Adverse Events
timeFrame: up to 24week post operation
Locations:
city: Hefei
country: China
facility: Anhui Province Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University Medical College
state: Shanxi
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical College
state: Yunnan
Study officials:
affiliation: Beijing Jishuitan Hospital
name: Wei Tian
role: PRINCIPAL_INVESTIGATOR
References: