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

Johnson & Johnson (J&J)

Status

Completed

Conditions

Spinal Tumor

Spondylolisthesis

Spinal Fracture

Spinal Stenosis

Spinal Deformity

Disc Degenerative Disease

Treatments

Device: Johnson&Johnson Medical Suzhou made Spine Fusion System

Device: Imported EXPEDIUM screws and OPAL cage

Study type

Interventional

Funder types

Industry

Identifiers

NCT02252185

DPS-201303

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.