Degenerative Disc DiseaseLOPAIN1NCT04141098
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy
A study testing All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. in people with Degenerative Disc Disease and Chronic Low-back Pain, run by Spinal Stabilization Technologies at 1 site in Paraguay.
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 21 to 60 years
- Conditions the study is for
- Degenerative Disc Disease, Chronic Low-back Pain
- What is being tested?
- All patients that meet the inclusion/exclusion criteria will receive the 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
- 1 siteParaguay
- Study dates
- 19 Sep 2019to 7 Aug 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient is skeletally mature and between 21 and 60 years of age.
- Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1
- History and clinical findings suggestive of symptomatic DDD:
- Darkened disc on MRI in T2 weighted images Patients with at least 6 months of low back pain (location defined as the space between the lower margin of the posterior rib cage and horizontal gluteal fold) that is resistant to nonsurgical conservative therapy.
- Patient has adequate disc height (~6mm) at the level to be treated
- Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale).
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- Patient has pre-operative back pain VAS 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
- Spinal fusion at any level
- Patient has ankylosing spondylitis or other spondyloarthropathy.
- Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
- Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
- Patient has significant facet disease.
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- Patient has had prior lumbar spine surgery
- Spinal fusion at any level
- Patient has any known active malignancy.
- Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.
- Patient has active local or systemic 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 is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by urine or serum HCG.
- 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 disabled, prisoner, chronic alcohol/ substance abuser)
- Patient has a significant disc herniation at the level to be treated
- Patient has a significant 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 as determined by imaging balloon during fluoroscopy
- Patient has a disc space that is too narrow for implantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy - LOPAIN1
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 and efficacy data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). Patients will have degenerative disc disease (DDD) in one or more lumbar discs. 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
- All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
- Keywords
- Degenerative Disc Disease, DDD, Chronic Low-back Pain, Disc Herniation, Nucleus Replacement, Low back pain
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.Device
All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board. Any patient meeting any of the three intraoperative exclusion criteria will receive an alternative standard of care therapy.
| Study group | Role | What they receive |
|---|---|---|
| Total Nucleus Replacement | Experimental | All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. Receives: Device: All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post surgical change in degree of disability
Patient reported outcomes for degree of disability will be monitored using the Oswestry Disability Index (scale of 0-100). Higher scores indicate greater level of disability.
Measured: 6 months
Post surgical change in back pain: Visual Analogue Scale
Patient reported outcomes will be reported using the Visual Analogue Scale (0-100mm). Higher scores indicate greater levels of back pain.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start19 Sep 2019
- Primary completion1 Feb 2023
- Study completion7 Aug 2023
Why it stopped: The clinical 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 will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB). Patients that cannot receive the implant due to an intraoperative exclusion, will receive standard of care treatment.
- 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-KlinikJeff Golan, MD, Study chair, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141098
- Sponsor's protocol ID
- CIP-003
- Acronym
- LOPAIN1
- Status last verified
- May 2025
- First submitted
- 24 Oct 2019
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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
- Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy - LOPAIN1
- ClinicalTrials.gov ID
- NCT04141098
- Acronym / sponsor ID
- LOPAIN1 / CIP-003
- Conditions
- Degenerative Disc Disease, Chronic Low-back Pain
- Keywords
- Degenerative Disc Disease, DDD, Chronic Low-back Pain, Disc Herniation, Nucleus Replacement, Low back pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical trial was terminated prematurely due to receipt of CE mark
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Spinal Stabilization TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 28 Oct 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 and efficacy data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). Patients will have degenerative disc disease (DDD) in one or more lumbar discs. 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 will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB). Patients that cannot receive the implant due to an intraoperative exclusion, will receive standard of care treatment.
| Arm | Type | Receives |
|---|---|---|
| Total Nucleus Replacement | Experimental | Device: All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient is skeletally mature and between 21 and 60 years of age.
- Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1
- History and clinical findings suggestive of symptomatic DDD:
- Darkened disc on MRI in T2 weighted images Patients with at least 6 months of low back pain (location defined as the space between the lower margin of the posterior rib cage and horizontal gluteal fold) that is resistant to nonsurgical conservative therapy.
- Patient has adequate disc height (~6mm) at the level to be treated
Key exclusion criteria (23 listed)
- Patient has had prior lumbar spine surgery
- Spinal fusion at any level
- Patient has ankylosing spondylitis or other spondyloarthropathy.
- Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
- Patient has congenital moderate or severe spinal 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 |
|---|---|---|
| All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board. Any patient meeting any of the three intraoperative exclusion criteria will receive an alternative standard of care therapy. | Device | Total Nucleus Replacement |
Primary outcome
Post surgical change in degree of disability
Time frame: 6 months
Patient reported outcomes for degree of disability will be monitored using the Oswestry Disability Index (scale of 0-100). Higher scores indicate greater level of disability.
Post surgical change in back pain: Visual Analogue Scale
Time frame: 6 months
Patient reported outcomes will be reported using the Visual Analogue Scale (0-100mm). Higher scores indicate greater levels of back pain.
Results and safety
The study was stopped early (reason given: The clinical 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
Jeff Golan, MD study chair
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. in people with Degenerative Disc Disease and Chronic Low-back Pain, run by Spinal Stabilization Technologies at 1 site in Paraguay.
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 9 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 1 site in Paraguay. 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: The clinical 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?
Post surgical change in degree of disability (time frame: 6 months). The study lists 2 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 2 Nov 2026.