Back Pain With RadiationLOPAIN3NCT05732818
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3
A study testing PerQdisc Nucleus Replacement System in people with Back Pain With Radiation and Radiculopathy, run by Spinal Stabilization Technologies at 2 sites in 2 countries.
Trial summary
This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL)… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Back Pain With Radiation, Radiculopathy, Back Pain
- What is being tested?
- PerQdisc Nucleus Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jun 2023to 16 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is skeletally mature and at least 21 years of age.
- Patient has a lumbar disc herniation, between L1-S1, with compressive radiculopathy of the traversing nerve root requiring partial discectomy or sequestrectomy. Only one lumbar disc may be treated with the PerQdisc device.
- Patient must have an overall disc herniation (extrusion or protrusion) such that half or less of the width of the dorsal annulus of the spinal canal, is affected by the herniation. The width of the canal is defined by the lateral recesses and the central canal (i.e. pedicle to pedicle).
- Patient must have a minimum of 6 mm of disc height as measured in the center of the affected disc.
- Patient is willing and able to give informed consent.
- All surgeries must be approved by at least 2 members of the Medical Advisory Board (MAB) - potential anatomical limitations of safely accessing Kambin's, extent of annular disruption, as well as overall patient criteria will be evaluated
Who cannot join
- Patient has had prior lumbar spine surgery at the index level (nucleoplasy is acceptable).
- Patient has had spinal fusion in the lumbar spine. Cervical or thoracic fusion is allowed as long as there are no neurologic deficits in the lower extremities.
- Patient has spondyloarthropathy or other spondylolisthesis greater than 4 mm or spondylolysis at the index level (on standing X-ray).
- Patient has underlying moderate or severe spinal stenosis (congenital, degenerative, or due to epidural lipomatosis) at any level. If the index level shows stenosis due to the disc herniation, it is acceptable if the index level is going to be treated concurrently with the PerQdsic procedure.
- Patient has compressive radiculopathy of the exiting nerve root at the index level.
- Patient has significant facet disease. Significant is defined as clinically confirmed by diagnostic block or radiologically grade 2 or higher (mild joint narrowing and irregularity are acceptable, but not sclerosis or osteophyte formation).
Show all 27Show fewer
- 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, AIDS related complex (ARC) and HIV.
- Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
- Patient has osteopenia of the spine (T-score of -1.0 or lower). All patients 50 years of age or older, and any post menopausal women with a history of fractures should have a dual x-ray absorptiometry (DEXA) scan to confirm exclusion.
- Patient has morbid obesity defined as a body mass index (BMI) more than 35 (>35).
- Patient has a known allergy to silicone or barium sulfate.
- Patient has a broad disc herniation that is wider than ½ of the dorsal annulus forming the wall of the spinal canal
- Patient requires decompression involving disruption of the midline bony-ligamentous elements (i.e. laminectomy).
- Patient has a significant Schmorl's node at the level to be treated, or any Schmorl's nodes affecting 3 or more lumbar levels. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).
- Patient has more than 20 degrees of mobility on flexion/extension radiographs at the index level
- Patient has more than 10 degrees of lumbar scoliosis.
- 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 is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by serum HCG. If patient becomes pregnant during the course of the study and wishes to continue study participation, a new Pregnancy Informed Consent must be completed.
- Intraoperative Exclusion:
- Poor radiological visualization of Kambin's triangle
- Patient has annular defect following surgical treatment of the disc herniation/protrusion that is greater than 6 mm
- Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite of repositioning instruments.
- Protrusion of the 50A 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 balloons during fluoroscopy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Uzbekistan1 site
Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
Tashkent, Tashkent, 100007
About this study
Official title: Clinical Investigation Plan First in Human Trial Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy "LOPAIN3"
This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.
Read the detailed description
The PerQdisc® Nucleus Replacement System is comprised of an in situ formed silicone-based prosthesis with its delivery system, implant fill device, dispenser gun, a disc access system and two different imaging balloons. For this trial, the PerQdisc® will be implanted using minimally invasive posterolateral (MIPL) approach. The implanted device provides an effective means of replacing dysfunctional nucleus pulposus while supporting the native annulus fibrosis to bridge annular defects.
Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis.
- Conditions
- Back Pain With Radiation, Radiculopathy, Back Pain, Disc Herniation, Herniated Nucleus Pulposus, Herniated Disc
- Being tested
- PerQdisc Nucleus Replacement System
- Medical subject headings
- Back Pain, Radiculopathy, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerQdisc Nucleus Replacement SystemDevice
Lumbar spine disc nucleus replacement system. 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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Disc Nucleus Replacement following discectomy | Experimental | 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. Receives: Device: PerQdisc Nucleus Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Patients with Serious Adverse Events related to the PerQdisc
Freedom from device- and procedure-related serious adverse events definitely related to the PerQdisc Device or the PerQdisc Surgical Procedure
Measured: 12 months
Secondary outcomes (24)
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Measured: 3 months
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Measured: 6 months
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Measured: 12 months
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Measured: 24 months
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Measured: 3 months
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Measured: 6 months
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Measured: 12 months
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Measured: 24 months
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Measured: 3 months
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Measured: 6 months
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Measured: 12 months
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Measured: 24 months
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Measured: 3 months
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Measured: 6 months
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Measured: 12 months
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Measured: 24 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Measured: 3 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Measured: 6 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Measured: 12 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Measured: 24 months
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Measured: 3 months
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Measured: 6 months
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Measured: 12 months
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start16 Jun 2023
- Primary completion16 Sep 2026 (estimated)
- Study completion16 Jun 2027 (estimated)
Why it stopped: The study was suspended as enrollment of patients was difficult and no participants could be found for two years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain With RadiationStudies 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
- Patients will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spinal Stabilization Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Raylytic GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732818
- Sponsor's protocol ID
- DPQ114.B: LOPAIN3
- Acronym
- LOPAIN3
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Plan First in Human Trial Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy "LOPAIN3"
- ClinicalTrials.gov ID
- NCT05732818
- Acronym / sponsor ID
- LOPAIN3 / DPQ114.B: LOPAIN3
- Conditions
- Back Pain With Radiation, Radiculopathy, Back Pain, Disc Herniation, Herniated Nucleus Pulposus, Herniated Disc
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study was suspended as enrollment of patients was difficult and no participants could be found for two years.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Spinal Stabilization TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Raylytic GmbH
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 16 Jun 2027 (estimated)
- First posted
- 17 Feb 2023 (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 is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.
Detailed description
The PerQdisc® Nucleus Replacement System is comprised of an in situ formed silicone-based prosthesis with its delivery system, implant fill device, dispenser gun, a disc access system and two different imaging balloons. For this trial, the PerQdisc® will be implanted using minimally invasive posterolateral (MIPL) approach. The implanted device provides an effective means of replacing dysfunctional nucleus pulposus while supporting the native annulus fibrosis to bridge annular defects.
Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB).
| Arm | Type | Receives |
|---|---|---|
| Lumbar Disc Nucleus Replacement following discectomy | Experimental | Device: PerQdisc Nucleus Replacement SystemAll patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is skeletally mature and at least 21 years of age.
- Patient has a lumbar disc herniation, between L1-S1, with compressive radiculopathy of the traversing nerve root requiring partial discectomy or sequestrectomy. Only one lumbar disc may be treated with the PerQdisc device.
- Patient must have an overall disc herniation (extrusion or protrusion) such that half or less of the width of the dorsal annulus of the spinal canal, is affected by the herniation. The width of the canal is defined by the lateral recesses and the central canal (i.e. pedicle to pedicle).
- Patient must have a minimum of 6 mm of disc height as measured in the center of the affected disc.
- Patient is willing and able to give informed consent.
Key exclusion criteria (27 listed)
- Patient has had prior lumbar spine surgery at the index level (nucleoplasy is acceptable).
- Patient has had spinal fusion in the lumbar spine. Cervical or thoracic fusion is allowed as long as there are no neurologic deficits in the lower extremities.
- Patient has spondyloarthropathy or other spondylolisthesis greater than 4 mm or spondylolysis at the index level (on standing X-ray).
- Patient has underlying moderate or severe spinal stenosis (congenital, degenerative, or due to epidural lipomatosis) at any level. If the index level shows stenosis due to the disc herniation, it is acceptable if the index level is going to be treated concurrently with the PerQdsic procedure.
- Patient has compressive radiculopathy of the exiting nerve root at the index level.
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 SystemLumbar spine disc nucleus replacement system. 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. | Device | Lumbar Disc Nucleus Replacement following discectomy |
Primary outcome
Safety: Number of Patients with Serious Adverse Events related to the PerQdisc
Time frame: 12 months
Freedom from device- and procedure-related serious adverse events definitely related to the PerQdisc Device or the PerQdisc Surgical Procedure
24 secondary outcomes
Performance: ODI
Time frame: 3 months
Performance: ODI
Time frame: 6 months
Performance: ODI
Time frame: 12 months
Performance: ODI
Time frame: 24 months
Performance: VAS Back
Time frame: 3 months
Performance: VAS Back
Time frame: 6 months
Performance: VAS Back
Time frame: 12 months
Performance: VAS Back
Time frame: 24 months
Performance: VAS Leg
Time frame: 3 months
Performance: VAS Leg
Time frame: 6 months
Performance: VAS Leg
Time frame: 12 months
Performance: VAS Leg
Time frame: 24 months
Performance: Analgesic Score
Time frame: 3 months
Performance: Analgesic Score
Time frame: 6 months
Performance: Analgesic Score
Time frame: 12 months
Performance: Analgesic Score
Time frame: 24 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Time frame: 3 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Time frame: 6 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Time frame: 12 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Time frame: 24 months
Safety: Number of Patient that Received Supplemental fixation
Time frame: 3 months
Safety: Number of Patient that Received Supplemental fixation
Time frame: 6 months
Safety: Number of Patient that Received Supplemental fixation
Time frame: 12 months
Safety: Number of Patient that Received Supplemental fixation
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Related trials for Back Pain With Radiation
Active, not recruiting
Burst Crossover Trial
Back Pain With Radiation, Pain, Postoperative
Not yet recruitingPhase 4
Dose Dependent Steroid Injections
Lumbar Radiculopathy, Sciatica
RecruitingPhase 4
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Radiculopathy, Lumbosacral Region, Back Pain With Radiation
Recruiting
AuriculoTherapy NeuroImaging
Low Back Pain, Chronic Low-back Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PerQdisc Nucleus Replacement System in people with Back Pain With Radiation and Radiculopathy, run by Spinal Stabilization Technologies at 2 sites in 2 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 27 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: paused, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Paraguay, Uzbekistan. 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?
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?
Safety: Number of Patients with Serious Adverse Events related to the PerQdisc (time frame: 12 months). 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 8 Jan 2026.