Degenerative Disc DiseaseLOPAIN2NCT05508360
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
A study testing PerQdisc Nucleus Replacement System in people with Degenerative Disc Disease and Chronic Low-back Pain, run by Spinal Stabilization Technologies at 11 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Degenerative Disc Disease, Chronic Low-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
- 72 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 22 Aug 2022to 22 Aug 2030
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Show all 24Show 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 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.
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 5 countries
Colombia7 sites
- Active, not recruiting
Cediul S.A.
Barranquilla, Atlántico
- Withdrawn
Fundación Campbell
Barranquilla, Atlántico
- Withdrawn
Sabbag Radiólogos S.A.
Barranquilla, Atlántico
- Active, not recruiting
Sociedad de Cirugia de Bogota- Hospital de San Jose
Bogotá, D.C.
- Active, not recruiting
Clínica Imbanaco de Cali S.A.
Cali, Valle del Cauca Department
- Active, not recruiting
CIGE: Centro de Imunologia y Genetica
Medellín, Antioquia
- Active, not recruiting
Fundacion Hospitalaria San Vicente de Paul
Medellín, Antioquia
Costa Rica1 site, 1 recruiting
- Recruiting
Life Science Center for Innovation Hospital Clinica Biblica
San José
Sofia Sanchez, +506-2522-1000, ssuarezs@ClinicaBiblica.com
Emmanuelle Vargas, MD
Panama1 site, 1 recruiting
- Recruiting
Pacífica Salud Hospital Punta Pacífica
Panama City, Provincia de Panamá
C&M Research S.A., +507 6860-4953, info@candmresearch.org
Dr. Ricardo Bermudez, MD
Paraguay1 site, 1 recruiting
- Recruiting
Sanatario Americano
Asunción, 1101
Carlos Cetraro, radiosolutionspy@gmail.com
Francisco Duarte, MD
Uzbekistan1 site, 1 recruiting
- Recruiting
Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
Tashkent
Dr. Abdufarrukh Karimov
About this study
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.
Read the 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.
- Conditions
- Degenerative Disc Disease, Chronic Low-back Pain
- Being tested
- PerQdisc Nucleus Replacement System
- Keywords
- Degenerative Disc Disease, DDD, Chronic Low Back Pain, cLBP, 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.
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 | 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.
Perfromance: ODI
Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Measured: 6 months
Perfromance: ODI
Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Measured: 12 months
Performance: VAS
Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
Measured: 6 months
Performance: VAS
Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)
Measured: 12 months
Safety: Expulsion & Device Failure
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
Measured: 6 months
Safety: Expulsion & Device Failure
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
Measured: 12 months
Secondary outcomes (7)
Safety: Revision Surgery
Incidence of revision surgery
Measured: 6 months, 12 months, and 5 years
Safety: Expulsion & Device Failure
Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's
Measured: 5 years
Performance: Disc Height
Preservation of intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline
Measured: 6 months, 12 months, and 5 years
Performance: 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
Measured: 6 months, 12 months, 5 years
Safety: Neurological Status
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
Measured: 6 months, 12 months, and 5 years
Performance: Analgesic Score
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)
Measured: 6 months, 12 months, and 5 years
Safety: SAE
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
Measured: 6 months, 12 months, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start22 Aug 2022
- Primary completion22 Aug 2027 (estimated)
- Study completion22 Aug 2030 (estimated)
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).
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
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
- NCT05508360
- Sponsor's protocol ID
- LOPAIN2
- Acronym
- LOPAIN2
- Status last verified
- Jan 2026
- First submitted
- 1 Aug 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No