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

Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252185
• Other study ID #: DPS-201303
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: December 2, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Johnson & Johnson Medical (Suzhou) Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disc Degenerative Disease
• Intervertebral Disc Degeneration
• Spinal Cord Neoplasms
• Spinal Deformity
• Spinal Fracture
• Spinal Fractures
• Spinal Neoplasms
• Spinal Stenosis
• Spinal Tumor
• Spondylolisthesis

Intervention

Device:
• Johnson&Johnson Medical Suzhou made Spine Fusion System
interventional device is Spine Fusion System that is manufactured by Johnson & Johnson Medical Suzhou Ltd.
• Imported EXPEDIUM screws and OPAL cage
Comparator in this study is active comparator.

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Anhui Province Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Kunming Medical College	Kunming	Yunnan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Xi'an Jiaotong University Medical College	Xi'an	Shanxi
China	Xijing Hospital	Xi'an	Shanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Medical (Suzhou) Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Number of events	up to 24week post operation	Yes
Primary	Change of Japanese Orthopaedic Association score	Questionnaire	Preoperation and 24week post operation	No
Secondary	Improvement rate of Japanese Orthopaedic Association score	Questionnaire	7day, 12week, and 24week post operation	No
Secondary	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	No
Secondary	Visual Analogue Score of low back and leg pain	Visual Analogue Scale	7day, 12week, and 24week post operation	No
Secondary	Wound healing	would healing are classified as 3 classes. (Class I, Class II, Class III)	7day, 12week, and 24week post operation	No