Degenerative Disc DiseaseNCT04004156
Safety Study for An Artificial Disc Nucleus Replacement to Treat Chronic Low Back Pain
A study testing PerQdisc® Nucleus Replacement Device. in people with Degenerative Disc Disease and Chronic Low-back Pain, run by Spinal Stabilization Technologies at 4 sites in 4 countries.
Trial summary
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain. Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Degenerative Disc Disease, Chronic Low-back Pain
- What is being tested?
- PerQdisc® Nucleus Replacement Device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Mar 2019to 23 Jan 2023
- 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 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient is skeletally mature and between 22 and 60 years of age.
- Patient has degenerative disc disease (DDD) at a single level between L1 and S1 as confirmed by:History and clinical findings suggestive of symptomatic DDD, Darkened disc on MRI in T2 weighted images, and decreased disc height (decreased greater than 2 mm compared to adjacent cranial or caudal disc height) with minimum disc height of 6 mm.
- Patient has pre-operative back pain VAS score of greater than or equal to 4 (0-10 scale).
- Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale).
- Patient has received conservative (non-surgical) treatment for back pain for a minimum of 6 months.
- Patient has signed the approved Informed Consent Form.
Who cannot join
- Patient has had prior lumbar spine surgery.
- Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
- Patient has ankylosing spondylitis or other spondyloarthropathy.
- Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
- Patient has congenital stenosis or epidural lipomatosis.
- Patient has significant facet disease.
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- Patient has any known active malignancy.
- Patient has previously undergone immunosuppressive therapy.
- Patient has active local or system infection.
- Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease, including AIDS, ARC and HIV
- Patient has diabetes mellitus (Type 1 or 2), requiring daily insulin management.
- Patient has osteopenia of the spine (T-score less than 1.0). All females 45 years of age or older and all males 50 or older should have a DEXA scan to confirm this exclusion.
- Patient has morbid obesity defined as body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs) over ideal body weight.
- Patient is pregnant or plans to become pregnant during the course of the study.
- Patient has a known allergy to silicone (polymer and balloon material) or barium sulfate (polymer).
- Patient participated in another investigational drug or device study within the past 30 days.
- Patient belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self assessments is compromised (e.g. developmentally disables, prisoner, chronic alcohol/ substance abuser)
- Patient has a disc herniation
- Patient has a Schmorl's node in the level to be treated
- Intraoperative exclusion criteria:
- Protrusion of the 20A imaging balloon up to or beyond the outer margin of the vertebra during the imaging steps.
- Patient has a violated endplate.
- Patient has a disc space that is too narrow.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Safety Study for An Artificial Disc Replacement "PerQdisc Nucleus Replacement Device" NUCLEUS 181
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
Read the detailed description
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain by maintaining disc height while preserving range of motion.
- Conditions
- Degenerative Disc Disease, Chronic Low-back Pain
- Being tested
- PerQdisc® Nucleus Replacement Device.
- Keywords
- Degenerative Disc Disease, DDD, Chronic Low-back Pain, Low Back Pain, Nucleus Replacement Device, Nucleus Pulposus, Disc Replacement, Back pain, Leg pain, Lumbar Spinal Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerQdisc® Nucleus Replacement Device.Device
All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
| Study group | Role | What they receive |
|---|---|---|
| Nucleus Replacement | Experimental | All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. Receives: Device: PerQdisc® Nucleus Replacement Device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of revision surgery at the treated level
Number of patients requiring surgeries to revise the implanted level in the spine divided by the total number of implant surgeries. Express in percentage (0-100)
Measured: 90 days
Rate of expulsion
The rate of device expulsion. The number of patients determined to have expulsed devices divided by the total number of patients receiving implants.Expressed in percentage (0-100)
Measured: 90 Days
Rate of new herniation at the treated level as determined by MRI
Herniation will be determine by MRI. A herniation will be defined as violation of the intervertebral annulus, including expulsion of nucleus material. The response will be yes/no as assessed by the radiologist. Rate will be determined by total number of herniations divided by the total number of implanted devices. Expressed in percentage (0-100)
Measured: 90 days
Rate of new radiculopathy
New complaint of leg pain will be recorded as a yes/no response. Any complaint of new radiculopathy not seen preoperatively. Expressed as total number of new radiculopathy complaints divided by total number of patients. Expressed in percentage (0-100)
Measured: 90 days
MRI assessment of the endplate Modic changes.
Changes to vertebral endplates will be assigned based on Modic classification of I,II or III comparing preoperative grade to grade at 90 days. Possible scores are I,II or III
Measured: 90 days
Rate of surgical procedure technical success
The number of devices successfully implanted divided by the number of successfully devices implanted + unsuccessful implants. Output will be in percentage (0-100)
Measured: 90 days
Improvement in degree of disability as measured by the Oswestry Disability Index (ODI)
Change in absolute Oswestry Index score at 90 days compared to the preoperative score, range is 0-100
Measured: 90 days
Improvement in back pain as measured by 10-centimeter Visual Analog Scale (VAS)
Change in the Visual Analogue Scale (VAS) for back and leg pain on a scale of 0-10 cm comparing preoperative scores to 90 days post-operative.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Mar 2019
- Primary completion17 Mar 2022
- Study completion23 Jan 2023
Why it stopped: Trial was terminated prematurely due to receipt of CE mark
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label study. Patients that are unable to receive an implant due to intraoperative exclusion will receive standard of care
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Stabilization Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hess, MD, Study chair, London Spine Clinic/ATOS-Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004156
- Sponsor's protocol ID
- N181
- Status last verified
- May 2025
- First submitted
- 26 Jun 2019
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study for An Artificial Disc Replacement "PerQdisc Nucleus Replacement Device" NUCLEUS 181
- ClinicalTrials.gov ID
- NCT04004156
- Acronym / sponsor ID
- N181
- Conditions
- Degenerative Disc Disease, Chronic Low-back Pain
- Keywords
- Degenerative Disc Disease, DDD, Chronic Low-back Pain, Low Back Pain, Nucleus Replacement Device, Nucleus Pulposus, Disc Replacement, Back pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated prematurely due to receipt of CE mark
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Spinal Stabilization TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 1 Jul 2019 (actual)
- 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.
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
Detailed description
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain by maintaining disc height while preserving range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label study. Patients that are unable to receive an implant due to intraoperative exclusion will receive standard of care
| Arm | Type | Receives |
|---|---|---|
| Nucleus Replacement | Experimental | Device: PerQdisc® Nucleus Replacement Device.All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient is skeletally mature and between 22 and 60 years of age.
- Patient has degenerative disc disease (DDD) at a single level between L1 and S1 as confirmed by:History and clinical findings suggestive of symptomatic DDD, Darkened disc on MRI in T2 weighted images, and decreased disc height (decreased greater than 2 mm compared to adjacent cranial or caudal disc height) with minimum disc height of 6 mm.
- Patient has pre-operative back pain VAS score of greater than or equal to 4 (0-10 scale).
- Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale).
- Patient has received conservative (non-surgical) treatment for back pain for a minimum of 6 months.
Key exclusion criteria (23 listed)
- Patient has had prior lumbar spine surgery.
- Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
- Patient has ankylosing spondylitis or other spondyloarthropathy.
- Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
- Patient has congenital stenosis or epidural lipomatosis.
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 |
|---|---|---|
| PerQdisc® Nucleus Replacement Device.All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. | Device | Nucleus Replacement |
Primary outcome
Rate of revision surgery at the treated level
Time frame: 90 days
Number of patients requiring surgeries to revise the implanted level in the spine divided by the total number of implant surgeries. Express in percentage (0-100)
Rate of expulsion
Time frame: 90 Days
The rate of device expulsion. The number of patients determined to have expulsed devices divided by the total number of patients receiving implants.Expressed in percentage (0-100)
Rate of new herniation at the treated level as determined by MRI
Time frame: 90 days
Herniation will be determine by MRI. A herniation will be defined as violation of the intervertebral annulus, including expulsion of nucleus material. The response will be yes/no as assessed by the radiologist. Rate will be determined by total number of herniations divided by the total number of implanted devices. Expressed in percentage (0-100)
Rate of new radiculopathy
Time frame: 90 days
New complaint of leg pain will be recorded as a yes/no response. Any complaint of new radiculopathy not seen preoperatively. Expressed as total number of new radiculopathy complaints divided by total number of patients. Expressed in percentage (0-100)
MRI assessment of the endplate Modic changes.
Time frame: 90 days
Changes to vertebral endplates will be assigned based on Modic classification of I,II or III comparing preoperative grade to grade at 90 days. Possible scores are I,II or III
Rate of surgical procedure technical success
Time frame: 90 days
The number of devices successfully implanted divided by the number of successfully devices implanted + unsuccessful implants. Output will be in percentage (0-100)
Improvement in degree of disability as measured by the Oswestry Disability Index (ODI)
Time frame: 90 days
Change in absolute Oswestry Index score at 90 days compared to the preoperative score, range is 0-100
Improvement in back pain as measured by 10-centimeter Visual Analog Scale (VAS)
Time frame: 90 days
Change in the Visual Analogue Scale (VAS) for back and leg pain on a scale of 0-10 cm comparing preoperative scores to 90 days post-operative.
Results and safety
The study was stopped early (reason given: Trial was terminated prematurely due to receipt of CE mark). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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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.
Michael Hess, MD study chair
London Spine Clinic/ATOS-Klinik
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PerQdisc® Nucleus Replacement Device. in people with Degenerative Disc Disease and Chronic Low-back Pain, run by Spinal Stabilization Technologies at 4 sites in 4 countries.
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 6 inclusion and 23 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: stopped early, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Canada, Croatia, Germany. 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 was stopped early (reason given: Trial was terminated prematurely due to receipt of CE mark). Results are not available in the source record.
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?
Rate of revision surgery at the treated level (time frame: 90 days). The study lists 8 primary outcomes in all. 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 21 May 2025; AzTrials last refreshed its copy on 1 Nov 2026.