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SuspendedNCT05732818LOPAIN3Updated Nov 9, 2026

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3

An interventional study of PerQdisc Nucleus Replacement System in Back Pain With Radiation, Radiculopathy and Back Pain, sponsored by Spinal Stabilization Technologies. Suspended at 2 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Spinal Stabilization Technologies · Not applicable, Interventional, and Treatment

Why this study was suspended
The study was suspended as enrollment of patients was difficult and no participants could be found for two years.
Updated Nov 9, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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) 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.

02

Conditions studied

  • Back Pain With Radiation
  • Radiculopathy
  • Back Pain
  • Disc Herniation
  • Herniated Nucleus Pulposus
  • Herniated Disc
  • Disc Injury
  • Disk Herniated Lumbar
03

In context

Back Pain

728 studies on the registry are indexed under Back Pain; 109 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 593 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Spinal Stabilization Technologies is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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 .
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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).
  • Patient has any known active .
  • Patient has previously undergone or currently on therapy. 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 disease including AIDS, AIDS related complex (ARC) and .
  • 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 (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 , 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.
Terms in these criteria, in plain language(7)

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.

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.

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Lumbar Disc Nucleus Replacement following discectomy

    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: PerQdisc Nucleus Replacement System

Interventions

  • DevicePerQdisc Nucleus Replacement System

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. Performance: ODI

    Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool

    Time frame: 3 months

  2. Performance: ODI

    Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool

    Time frame: 6 months

  3. Performance: ODI

    Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool

    Time frame: 12 months

  4. Performance: ODI

    Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool

    Time frame: 24 months

  5. Performance: VAS Back

    Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)

    Time frame: 3 months

  6. Performance: VAS Back

    Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)

    Time frame: 6 months

  7. Performance: VAS Back

    Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)

    Time frame: 12 months

  8. Performance: VAS Back

    Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)

    Time frame: 24 months

  9. Performance: VAS Leg

    Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)

    Time frame: 3 months

  10. Performance: VAS Leg

    Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)

    Time frame: 6 months

  11. Performance: VAS Leg

    Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)

    Time frame: 12 months

  12. Performance: VAS Leg

    Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)

    Time frame: 24 months

  13. 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)

    Time frame: 3 months

  14. 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)

    Time frame: 6 months

  15. 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)

    Time frame: 12 months

  16. 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)

    Time frame: 24 months

  17. Safety: Number of Patients with Reherniation/recurrent disc herniation

    Freedom from reherniation/recurrent disc herniation

    Time frame: 3 months

  18. Safety: Number of Patients with Reherniation/recurrent disc herniation

    Freedom from reherniation/recurrent disc herniation

    Time frame: 6 months

  19. Safety: Number of Patients with Reherniation/recurrent disc herniation

    Freedom from reherniation/recurrent disc herniation

    Time frame: 12 months

  20. Safety: Number of Patients with Reherniation/recurrent disc herniation

    Freedom from reherniation/recurrent disc herniation

    Time frame: 24 months

  21. 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

    Time frame: 3 months

  22. 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

    Time frame: 6 months

  23. 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

    Time frame: 12 months

  24. 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

    Time frame: 24 months

Other outcomes

  1. Exploratory Endpoint: Disch Height

    Disc height in millimeters at each clinical visit as measured on plain film X-ray

    Time frame: 3 months

  2. Exploratory Endpoint: Disch Height

    Disc height in millimeters at each clinical visit as measured on plain film X-ray

    Time frame: 6 months

  3. Exploratory Endpoint: Disch Height

    Disc height in millimeters at each clinical visit as measured on plain film X-ray

    Time frame: 12 months

  4. Exploratory Endpoint: Disch Height

    Disc height in millimeters at each clinical visit as measured on plain film X-ray

    Time frame: 24 months

  5. Exploratory Endpoint: RoM

    Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs

    Time frame: 3 months

  6. Exploratory Endpoint: RoM

    Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs

    Time frame: 6 months

  7. Exploratory Endpoint: RoM

    Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs

    Time frame: 12 months

  8. Exploratory Endpoint: RoM

    Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs

    Time frame: 24 months

  9. Exploratory Endpoint: Neurological Status

    Maintenance and/or improvement of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale

    Time frame: 3 months

  10. Exploratory Endpoint: Neurological Status

    Maintenance and/or improvement of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale

    Time frame: 6 months

  11. Exploratory Endpoint: Neurological Status

    Maintenance and/or improvement of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale

    Time frame: 12 months

  12. Exploratory Endpoint: Neurological Status

    Maintenance and/or improvement of baseline neurologic status through physical assessment evaluating nerve compression at baseline and post-surgical follow-up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale

    Time frame: 24 months

07

Study locations

2 sites
  • Sanatorio Americano
    Asunción, 1101, Paraguay
  • Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
    Tashkent, Tashkent 100007, Uzbekistan
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Jun 2023 (actual). Primary completion is estimated for Sep 2027, 51 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Sep 2026 → Sep 2027 and completion Jun 2027 → Jun 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2023
First posted
Feb 17, 2023
StartActual
Jun 16, 2023
Primary completionEst.
Sep 16, 2027was Sep 2026
CompletionEst.
Jun 16, 2028was Jun 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Sep 16, 2026→Sep 16, 2027
Nov 9, 2026
Study completion
Jun 16, 2027→Jun 16, 2028
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Primary completion Sep 16, 2026→Sep 16, 2027
    Study completion Jun 16, 2027→Jun 16, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05732818
Lead sponsor
Spinal Stabilization Technologies
Collaborators
Raylytic GmbH
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
Jun 16, 2023
Primary completion
Sep 16, 2027 (estimated)
Completion
Jun 16, 2028 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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