"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) (LOPAIN2)

May 25, 2026 updated by: Spinal Stabilization Technologies
This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be a prospective, open-label, multi-center study that will collect additional 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 any standard anterior, standard lateral, or minimally invasive posterolateral surgical 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
        • Active, not recruiting
        • CIGE: Centro de Imunologia y Genetica
      • Medellín, Antioquia, Colombia
        • Active, not recruiting
        • Fundación Hospitalaria San Vicente de Paul
    • Atlántico
      • Barranquilla, Atlántico, Colombia
        • Active, not recruiting
        • Cediul S.A.
      • Barranquilla, Atlántico, Colombia
        • Withdrawn
        • Fundación Campbell
      • Barranquilla, Atlántico, Colombia
        • Withdrawn
        • Sabbag Radiólogos S.A.
    • D.C.
      • Bogotá, D.C., Colombia
        • Active, not recruiting
        • Sociedad de Cirugia de Bogota- Hospital de San Jose
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia
        • Active, not recruiting
        • Clínica Imbanaco de Cali S.A.
  • Panama
    • Provincia de Panamá
      • Panama City, Provincia de Panamá, Panama
        • Recruiting
        • Pacífica Salud Hospital Punta Pacífica
        • Principal Investigator:
          • Dr. Ricardo Bermudez, MD
        • Contact:
  • Paraguay
      • Asunción, Paraguay, 1101
        • Recruiting
        • Sanatario Americano
        • Contact:
        • Principal Investigator:
          • Francisco Duarte, MD
  • Uzbekistan
      • Tashkent, Uzbekistan
        • Recruiting
        • Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
        • Principal Investigator:
          • Dr. Abdufarrukh Karimov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is skeletally mature aged 22-70.
  • Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.
  • Patient has adequate disc height (6mm) at the level to be treated
  • Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).
  • Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40/100)
  • Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)
  • Patient has signed the approved Informed Consent Form.
  • All surgeries must be approved by the Medical Advisory Board (MAB)

Exclusion Criteria:

  • Patient has less than 6 mm of disc height.
  • Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
  • Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.
  • Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
  • Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
  • Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).
  • 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 or local 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 has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan should be performed to rule out patients considered at risk for osteopenia.
  • Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.
  • Patient has a known allergy to silicone or barium sulfate.
  • Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.
  • Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).
  • Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
  • 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)

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 balloons during fluoroscopy.
  • Patient has a disc space that is too narrow for implantation. MIPL Specific
  • Poor radiological visualization of Kambin's triangle.
  • 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 or repositioning instruments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lumbar Disc Nucleus Replacement
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perfromance: ODI
Time Frame: 6 months
Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
6 months
Perfromance: ODI
Time Frame: 12 months
Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
12 months
Performance: VAS
Time Frame: 6 months
Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
6 months
Performance: VAS
Time Frame: 12 months
Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
12 months
Safety: Expulsion & Device Failure
Time Frame: 6 months
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
6 months
Safety: Expulsion & Device Failure
Time Frame: 12 months
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety: Revision Surgery
Time Frame: 6 months, 12 months, and 5 years
Incidence of revision surgery
6 months, 12 months, and 5 years
Safety: Expulsion & Device Failure
Time Frame: 5 years
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
5 years
Performance: Disc Height
Time Frame: 6 months, 12 months, and 5 years
Preservation of intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline
6 months, 12 months, and 5 years
Performance: RoM
Time Frame: 6 months, 12 months, 5 years
Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs
6 months, 12 months, 5 years
Safety: Neurological Status
Time Frame: 6 months, 12 months, and 5 years
Maintenance 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
6 months, 12 months, and 5 years
Performance: Analgesic Score
Time Frame: 6 months, 12 months, and 5 years
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale ranging from 0 (no meds) - 4 (high dose opioids)
6 months, 12 months, and 5 years
Safety: SAE
Time Frame: 6 months, 12 months, and 5 years
Incidence of serious adverse events that are related to the surgical procedure or Incidence of Serious Adverse Events related to the surgical procedure or device
6 months, 12 months, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spinal Stabilization Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Michael Hess, MD, London Spine Clinic/ATOS-Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOPAIN2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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