Phase
Condition
Chronic Pain
Treatment
PerQdisc
Clinical Study ID
Ages 22-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Skeletally mature male or female subjects aged 22-70 (inclusive).
Subject has a primary diagnosis of single level discogenic back pain caused bydegenerative disc disease (L1 to L5) identified via MRI.
Subject has an intact annulus (as determined by MRI) and endplates (as determined byMRI and X-ray) at the level to be treated.
Subject must have failed to respond to a minimum of 6 months of conservativetreatment for their back pain (e.g., physical therapy, medications, injections,ablations, lifestyle changes, etc.).
Subject has a low back pain VAS ≥40 mm (4 cm).
Subject has adequate disc height (≥6mm measured at the center of the disc) at thelevel to be treated. [As measured by the investigator]
Subject is psychosocially, mentally and physically able and willing to fully complywith this protocol including adhering to follow-up schedule and requirements andfilling out forms.
Subject has read and understands the IRB approved informed consent document prior tosigning and dating the document and before the initiation of any study-relatedprocedures
Subject is appropriate candidate for the PerQdisc surgical approach [as defined inthe surgical technique guide].
Exclusion
Exclusion Criteria:
Subject has symptomatic degenerative disc disease at more than one lumbar level
Subject has had a prior spinal fusion in the lumbar or thoracic intervertebralspaces.
Subject has had a prior SI-joint fusion.
Subject has a spinal cord stimulator.
Subject has had any prior lumbar spine surgery (instrumented or non-instrumented)
Subject has a significant disc herniation at the level to be treated. Significant isdefined as a large, extruded herniation that creates a risk for expulsion.
Subject has congenital moderate or severe spinal stenosis or epidural lipomatosis.
Subject has spondylolisthesis (antero- or retrolisthesis) in static X-ray ≥3 mm [measured via neutral lateral x-ray]
Subject has ≥4 mm dynamic spondylolisthesis [measured via flexion/extension x-rays]
Subject has > 20 degree range of motion at the index level [measured viaflexion/extension x-rays]
Subject has a history of any invasive malignancy (except non-melanoma skin cancer)unless treated with curative intent and there have been no clinical signs orsymptoms of malignancy for at least 5 years (in particular, spinal tumors).
Subject has an active systemic infection or infection at the operative site.
Subject has evidence of symptomatic facet joint degeneration or disease where theinvestigator feels the facet is a major contributor to the subject's pain asdiagnosed by injection and/or imaging.
Subject has a known allergy to silicone or barium sulfate.
Subject has been diagnosed with fibromyalgia, hepatitis, rheumatoid arthritis, lupuserythematosus, AIDs, ARC, HIV, or an autoimmune disease that affects themusculoskeletal system.
Subject has been diagnosed with Paget's disease, osteomalacia or any other metabolicbone disease.
Subject has current or recent history (defined ≤ 1 year prior to screening) ofsubstance abuse (alcoholism and/or narcotic addiction) using standard medicaldefinitions of DSM-5
Subject has morbid obesity defined as a body mass index (BMI) > 40.
Subject participated in an investigational drug or another medical device studywithin the last 30 days prior to surgery.
Subject has Osteoporosis, defined as a T-score ≤ -2.5.
An existing DEXA is allowed if completed within 6 months of subject surgery.
For all subjects without an existing DEXA, the SCORE/MORES will be utilized toscreen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scanis required.
Female subjects who are pregnant or are trying to become pregnant during the courseof the trial.
Subject has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
Subject belongs to a vulnerable population or has a condition such that his/herability to provide informed consent, comply with follow-up requirements, or provideself-assessments is compromised (e.g. developmentally disabled, prisoner, chronicalcohol/ substance abuser)
Subject is currently receiving worker's compensation or is involved in anylitigation for medical negligence, trauma, or worker's compensation.
Subject has lumbar scoliosis > 10 degrees at index level.
Subject has a large, rectangular or irregularly shaped Schmorl's node with anassociated active inflammatory process (Modic I changes).
Subject has motion of < 3 degrees on pre-operative lateral flexion/extensionradiographs at index level.
Subject has opioid medication usage > 60 MME (morphine milligram equivalent)/day orchange in opioid prescription within 60 days of surgery.
Subject has a preoperative VAS right or left leg pain score > the preoperative VASBack score.
Subject has a history of vertebral fractures in the lumbar spine.
Subject has evidence of severe compression of cauda equina.
Subject is on chronic anticoagulation therapy due to a bleeding disorder and isunable to safely stop anticoagulants or has taken anticoagulants within 3 days priorto procedure.
Subject has low back pain (LBP) of non-spinal or unknown etiology.
Subject is unable to undergo X-ray, MRI, or other radiographic assessments,including discography.
Subject has a degenerative muscular or neurological condition that would interferewith evaluation of outcomes, including but not limited to spinal disease (not atindex level), Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiplesclerosis.
Subject has, in the opinion of the investigator, a behavioral, cognitive, social ormedical problem that may interfere with the assessment of the safety oreffectiveness of the device.
In the opinion of the investigator the subject has a major psychiatric disorder thatmay interfere with the assessment of the safety or effectiveness of the device.
Subject has myelopathy.
Subject has primarily leg pain with associated nerve root compression, in theopinion of the investigator.
Subject has an annular defect greater than 6mm that extends from the interior of thedisc to the outer margin of the annulus as evaluated on MRI.
Study Design
Study Description
Connect with a study center
HOPE Research Institute
Glendale, Arizona 85308
United StatesActive - Recruiting
HOPE Research Institute
Phoenix, Arizona 85032
United StatesActive - Recruiting
HonorHealth Research & Innovation Institute
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Spine Institute of Louisiana
Shreveport, Louisiana 71101
United StatesActive - Recruiting
SonoSpine
Oklahoma City, Oklahoma 73159
United StatesSite Not Available
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