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

Not Applicable

Completed

• Conditions: Spinal Fracture; Spondylolisthesis; Spinal Deformity; Spinal Stenosis; Disc Degenerative Disease; Spinal Tumor
• Interventions: Device: Imported EXPEDIUM screws and OPAL cage; Device: Johnson&Johnson Medical Suzhou made Spine Fusion System

• Registration Number: NCT02252185
• Lead Sponsor: Johnson & Johnson Medical (Suzhou) Ltd.

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Status Verified: 2015-03
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imported spine fusion system	Imported EXPEDIUM screws and OPAL cage	patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .
China made spine fusion system	Johnson&Johnson Medical Suzhou made Spine Fusion System	patents in this arm will be implanted with Johnson\&Johnson Medical Suzhou made Spine Fusion System.

Primary Outcome Measures

Name	Time	Method
Change of Japanese Orthopaedic Association score	Preoperation and 24week post operation	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Score of low back and leg pain	7day, 12week, and 24week post operation	Visual Analogue Scale
Wound healing	7day, 12week, and 24week post operation	would healing are classified as 3 classes. (Class I, Class II, Class III)
Improvement rate of Japanese Orthopaedic Association score	7day, 12week, and 24week post operation	Questionnaire
Fixation stability	12week, and 24week post operation	Fixation stability should be measured based on translational motion and angular motion which is demonstrated on X-Ray examination (A/P lateral, Flexion and extension).

Trial Locations

Locations (8)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Xijing Hospital; 🇨🇳 Xi'an, Shanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University Medical College; 🇨🇳 Xi'an, Shanxi, China

The First Affiliated Hospital of Kunming Medical College; 🇨🇳 Kunming, Yunnan, China

Anhui Province Hospital; 🇨🇳 Hefei, Anhui, China

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China

Jiangxi Provincial People's Hospital; 🇨🇳 Nanchang, Jiangxi, China

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China