Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02252185
Other study ID # DPS-201303
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT06290908 - RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
Withdrawn NCT03223701 - Efficacy of Using Solum IV and BMC With GFC in TLIF Phase 4
Recruiting NCT03883022 - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery N/A
Completed NCT02902380 - The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery N/A
Not yet recruiting NCT06024785 - Vertebropexy - Randomized-controlled Trial N/A
Not yet recruiting NCT06000319 - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Completed NCT02454400 - Pre-surgery Physiotherapy for Patients With Specific Low Back Pain N/A
Completed NCT01377623 - Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion N/A
Completed NCT00996073 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion Phase 2
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Completed NCT00320619 - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery N/A
Completed NCT00022776 - Surgical Versus Nonsurgical Treatment for Spinal Stenosis Phase 3
Completed NCT06060821 - Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
Recruiting NCT04552145 - Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis N/A
Active, not recruiting NCT04379921 - Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch N/A
Withdrawn NCT04315090 - Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
Completed NCT04591249 - Physical Activity Intervention for Patients Following Lumbar Spine Surgery N/A
Recruiting NCT04601363 - Personalized Spine Study Group (PSSG) Registry
Completed NCT04193488 - Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery N/A