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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230088
      • Anhui Province Hospital
  • Beijing
    • Beijing, Beijing, China, 100035
      • Beijing Jishuitan Hospital
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Shanghai Ruijin Hospital
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Xijing Hospital
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University Medical College
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • The First Affiliated Hospital of Kunming Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: China made spine fusion system; patents in this arm will be implanted with Johnson&Johnson Medical Suzhou made Spine Fusion System.	Device: Johnson&Johnson Medical Suzhou made Spine Fusion System; interventional device is Spine Fusion System that is manufactured by Johnson & Johnson Medical Suzhou Ltd.
Active Comparator: Imported spine fusion system; patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .	Device: Imported EXPEDIUM screws and OPAL cage; Comparator in this study is active comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Japanese Orthopaedic Association score	Questionnaire	Preoperation and 24week post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement rate of Japanese Orthopaedic Association score	Questionnaire	7day, 12week, and 24week post operation
Fixation stability	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).	12week, and 24week post operation
Visual Analogue Score of low back and leg pain	Visual Analogue Scale	7day, 12week, and 24week post operation
Wound healing	would healing are classified as 3 classes. (Class I, Class II, Class III)	7day, 12week, and 24week post operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of events	up to 24week post operation

Collaborators and Investigators

• Sponsor: Johnson & Johnson Medical (Suzhou) Ltd.
• Investigators: Principal Investigator: Wei Tian, Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Spinal Injuries; Back Injuries; Bone Neoplasms; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spinal Fractures; Spondylolisthesis; Spinal Cord Neoplasms; Spinal Neoplasms
• Other Study ID Numbers: DPS-201303