Disc Degenerative DiseaseNCT02252185
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
A study testing Johnson&Johnson Medical Suzhou made Spine Fusion System and Imported EXPEDIUM screws and OPAL cage in people with Disc Degenerative Disease and Spondylolisthesis, run by Johnson & Johnson Medical (Suzhou) Ltd. at 8 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture
- What is being tested?
- Johnson&Johnson Medical Suzhou made Spine Fusion System and Imported EXPEDIUM screws and OPAL cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 8 sitesChina
- Study dates
- Jul 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Anhui Province Hospital
Hefei, Anhui, 230088
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, 650032
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Xijing Hospital
Xi’an, Shanxi, 710032
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi’an, Shanxi, 710061
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
About this study
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
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.
Read the 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.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity, Spinal Stenosis, Spinal Tumor
- Being tested
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Spinal Fractures, Spinal Stenosis, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Johnson&Johnson Medical Suzhou made Spine Fusion SystemDevice
interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.
Imported EXPEDIUM screws and OPAL cageDevice
Comparator in this study is active comparator.
| Study group | Role | What they receive |
|---|---|---|
| China made spine fusion system | Experimental | patents in this arm will be implanted with Johnson\&Johnson Medical Suzhou made Spine Fusion System. Receives: Device: Johnson&Johnson Medical Suzhou made Spine Fusion System |
| Imported spine fusion system | Active comparator | patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage . Receives: Device: Imported EXPEDIUM screws and OPAL cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Japanese Orthopaedic Association score
Questionnaire
Measured: Preoperation and 24week post operation
Secondary outcomes (4)
Improvement rate of Japanese Orthopaedic Association score
Questionnaire
Measured: 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).
Measured: 12week, and 24week post operation
Visual Analogue Score of low back and leg pain
Visual Analogue Scale
Measured: 7day, 12week, and 24week post operation
Wound healing
would healing are classified as 3 classes. (Class I, Class II, Class III)
Measured: 7day, 12week, and 24week post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc Degenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Tian, Principal investigator, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252185
- Sponsor's protocol ID
- DPS-201303
- Status last verified
- Mar 2015
- First submitted
- 24 Sep 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02252185
- Acronym / sponsor ID
- DPS-201303
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity, Spinal Stenosis, Spinal Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| China made spine fusion system | Experimental | Device: Johnson&Johnson Medical Suzhou made Spine Fusion Systempatents in this arm will be implanted with Johnson\&Johnson Medical Suzhou made Spine Fusion System. |
| Imported spine fusion system | Active comparator | Device: Imported EXPEDIUM screws and OPAL cagepatents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage . |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Johnson&Johnson Medical Suzhou made Spine Fusion Systeminterventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd. | Device | China made spine fusion system |
| Imported EXPEDIUM screws and OPAL cageComparator in this study is active comparator. | Device | Imported spine fusion system |
Primary outcome
Change of Japanese Orthopaedic Association score
Time frame: Preoperation and 24week post operation
Questionnaire
4 secondary outcomes
Improvement rate of Japanese Orthopaedic Association score
Time frame: 7day, 12week, and 24week post operation
Fixation stability
Time frame: 12week, and 24week post operation
Visual Analogue Score of low back and leg pain
Time frame: 7day, 12week, and 24week post operation
Wound healing
Time frame: 7day, 12week, and 24week post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Tian principal investigator
Beijing Jishuitan Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Johnson&Johnson Medical Suzhou made Spine Fusion System and Imported EXPEDIUM screws and OPAL cage in people with Disc Degenerative Disease and Spondylolisthesis, run by Johnson & Johnson Medical (Suzhou) Ltd. at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Japanese Orthopaedic Association score (time frame: Preoperation and 24week post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.