A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery

Johnson & Johnson Medical (Suzhou) Ltd.8 sites in 1 country106 target enrollmentJuly 2014

ConditionsDisc Degenerative Disease Spondylolisthesis Spinal Fracture Spinal Deformity Spinal Stenosis Spinal Tumor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Disc Degenerative Disease
Sponsor: Johnson & Johnson Medical (Suzhou) Ltd.
Enrollment: 106
Locations: 8
Primary Endpoint: Change of Japanese Orthopaedic Association score
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Medical (Suzhou) Ltd.

Responsible Party

Sponsor

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≥
•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)

Outcomes

Primary Outcomes

Change of Japanese Orthopaedic Association score

Time Frame: Preoperation and 24week post operation

Questionnaire

Secondary Outcomes

Visual Analogue Score of low back and leg pain(7day, 12week, and 24week post operation)
Wound healing(7day, 12week, and 24week post operation)
Improvement rate of Japanese Orthopaedic Association score(7day, 12week, and 24week post operation)
Fixation stability(12week, and 24week post operation)