An interventional study of Johnson&Johnson Medical Suzhou made Spine Fusion System and Imported EXPEDIUM screws and OPAL cage in Disc Degenerative Disease, Spondylolisthesis and Spinal Fracture, sponsored by Johnson & Johnson Medical (Suzhou) Ltd.. Completed at 8 sites in China. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.
Sponsored by Johnson & Johnson Medical (Suzhou) Ltd. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
Among 17 studies in Intervertebral Disc Degeneration with a site in China — 3 open to participants now, 3 under way, none of them phase 3. Intervertebral Disc Degeneration · China.
Among the 17 studies in Intervertebral Disc Degeneration with a site in China, this one is the only one that started in 2014, is one of 5 with no phase, and was the 3rd registered.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
Browse Intervertebral Disc Degeneration studies →3 of the 17 studies in Intervertebral Disc Degeneration with a site in China are open now. Recruiting first, the newest first:
Zhongda Hospital · Sites in China
Peking University Third Hospital · Sites in China
Peking University Third Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 60 Intervertebral Disc Degeneration studies recruiting now, 29 (48%) set no upper age limit and 16 (27%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 20 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 1 · Phase 3 1
First in 2010; this study’s year is marked. 1 started in 2014.
This study's enrollment of 106 is above the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.
Median enrollment 103 across the 8 interventional studies, 300 across the 9 observational. Of the 6 that completed or were terminated, 2 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 17 have an industry lead sponsor. The 10 most frequent:
Johnson & Johnson Medical (Suzhou) Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Johnson & Johnson Medical (Suzhou) Ltd. has 1 study filed under Intervertebral Disc Degeneration — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 17 studies in Intervertebral Disc Degeneration with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .
Device: Imported EXPEDIUM screws and OPAL cage
interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.
Comparator in this study is active comparator.
Change of Japanese Orthopaedic Association score
Questionnaire
Time frame: Preoperation and 24week post operation
Improvement rate of Japanese Orthopaedic Association score
Questionnaire
Time frame: 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).
Time frame: 12week, and 24week post operation
Visual Analogue Score of low back and leg pain
Visual Analogue Scale
Time frame: 7day, 12week, and 24week post operation
Wound healing
would healing are classified as 3 classes. (Class I, Class II, Class III)
Time frame: 7day, 12week, and 24week post operation
Adverse Events
Number of events
Time frame: up to 24week post operation
The record gives a start of Jul 2014, a primary completion of Sep 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →