HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Study Overview
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Brief Summary
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A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.

Detailed Description
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This pivotal study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial chronic low back pain (CLBP) due to degenerative disc disease (DDD) who continue to have severe back pain and dysfunction after at least six (6) months of conservative care.

Official Title
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HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Conditions
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Degenerative Disc Disease (DDD)

Intervention / Treatment
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* Device: The ReGelTec HYDRAFIL™ System
* Other: Conservative Care Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 22 to 85 years, inclusive Present with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration The presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may be treated during the study) as determined by discography Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann scale as determined by MRI Failure to have their symptoms resolve or reduce following six (6) months conservative care (as defined in the body of the protocol) Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms English fluency Signed informed consent Exclusion Criteria: History of or active systemic or local infection Any skin disease or inadequate tissue coverage at the site of the proposed injection Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography Presence of more than two (2) symptomatic discs presenting with pain confirmed during discography Presence of extruded or sequestered disc herniation (i.e., disc extrusions or sequestrations) at the symptomatic level(s) or on adjacent levels Presence of wide annular fissures confluent with large disc protrusions at the symptomatic level(s) Epidural steroid injection, intradiscal injection, trigger point injection, facet or medial branch block within 60 days of enrollment Opioid medication usage >60 MME (morphine milligram equivalent)/day or change/increase in opioid prescription within 60 days of enrollment Subjects with Modic type 3 changes Subjects presenting with radicular pain greater than back pain or by history within the past six (6) months. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed Neurogenic claudication due to spinal stenosis Subjects with any prior back surgery or invasive spinal procedure of the lumbar spine History of vertebral fractures in the lumbar spine Evidence of severe compression of cauda equina Spinal segmental instability (spondylolysis or spondylolisthesis: Grade >1), severe spinal canal stenosis, isthmus pathology, scoliosis [Cobb angle >20 at the index level(s)] Subjects with arachnoiditis Subjects who are prisoners of wards or courts Subjects involved in active litigation including worker's compensation cases Subjects on chronic anticoagulation due to a bleeding disorder and is unable to safely stop anticoagulants or has taken anticoagulants within three (3) days prior to procedure Subjects with LBP of non-spinal or unknown etiology Subjects who have a history (in the last 5 years) of substance abuse or chemical dependency (pharmaceuticals, illicit drugs, alcohol) or are current abusers (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)) Subjects who have major psychiatric disorders, such as major depression, bipolar disorder and schizophrenia, as defined by the DSM-V If female, subjects who are pregnant or are trying to become pregnant during the course of the trial (due to risks of additional radiation exposures) Failure to understand informed consent or inability or unwillingness to adhere to the study follow-up visit schedule or other protocol requirements Have participated in any other clinical trial within the last three (3) months, and active or planned participation in any other clinical study during the course of this trial. Note: subjects must agree they will not participate in any other investigational clinical trial during this study Body Mass Index (BMI) >35 kg/m2 Current smoker or nicotine and/ or tobacco user Known allergy or hypersensitivity to device material Endocrine or metabolic disorder known to affect osteogenesis Insulin-dependent diabetes mellitus Inability to undergo X-ray, MRI (magnetic resonance imaging), or CT (computed tomography) scans or other radiographic assessments, including discography Any comorbid medical condition which, in the best judgement of the Investigator, would make the subject unsuitable for inclusion in the study or interferes with the proper assessment of safety or effectiveness (e.g., systemic disease) Subjects with any active malignancy or who have been previously diagnosed with a malignancy and have evidence of residual disease Any degenerative or neurological condition that would interfere with evaluation of outcomes or that may generate an unacceptable risk of failure or postoperative complications Chronic or acute renal and/ or hepatic impairment Severe osteoporosis. The SCORES/MORES will be utilized to screen if a DEXA scan is indicated. If SCORES/MORES value ≥ 6; then a DEXA scan is required. Severe osteoporosis is defined as DEXA T-score < 2.5 (spine or hip) or QCT T-score < 80mg/cubic cm

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, dual arm, randomized, controlled pivotal study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Group A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the Treatment Arm) | Device: The ReGelTec HYDRAFIL™ System<br>* The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.<br>Other: Conservative Care Management<br>* Conservative care management (including physical therapy and/or pain medication)<br>* Other names: Non-surgical conservative medical management;|
| Sham Comparator: Control Arm<br>Group B: continued non-surgical conservative medical management plus advancement of the HYDRAFIL System delivery needle to the outside of the target disc(s) without contacting the outer edge of the annular fibers (the Control Arm) | Other: Conservative Care Management<br>* Conservative care management (including physical therapy and/or pain medication)<br>* Other names: Non-surgical conservative medical management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Endpoint of Clinical Success | The primary endpoint is a single composite endpoint reflecting five study outcomes (function, SAEs, SSIs, intercurrent events, and radiographic findings). The individual subject's outcome will be considered a success if all of the criteria are met at 12 months. | 12-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervertebral Disc, Nucleus Pulposus, Disc Augmentation