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New treatment option for Degenerative Disc Disease (DDD)
Official title HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
ClinicalTrials.gov ID: NCT06011551
What this study is testing
- What it's testing
- A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 85
You may be able to join if
- Male or female people aged 22 to 85 years, inclusive
- people presenting with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration
- 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 at least six (6) months of conservative care (as defined in the body of the protocol)
You likely can't join if
- 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)
See the full eligibility criteria
Who can join
- Male or female people aged 22 to 85 years, inclusive
- people presenting with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration
- 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 at least six (6) months of 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
What rules you out
- 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 increase in opioid use within 60 days of enrollment
- Evidence of Modic type 3 changes
- people 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...
- Evidence of neurogenic claudication due to spinal stenosis
- people with any prior back surgery on the lumbar spine
- History of vertebral fractures in the lumbar spine
- Evidence of severe compression of cauda equina
- Evidence of spinal segmental instability (spondylolysis or spondylolisthesis: Grade \>1), severe spinal canal stenosis, isthmus pathology, or scoliosis [Cobb angle \>20 at the index level(s)]
- people with arachnoiditis
- people who are prisoners or wards of courts
- people involved in active litigation including worker's compensation cases
- people on chronic anticoagulation due to a bleeding disorder and unable to safely stop anticoagulants, or has taken anticoagulants within three (3) days prior to procedure
- people with LBP of non-spinal or unknown etiology
- people who have a history (in the last five (5) years) of substance abuse or chemical dependency (pharmaceuticals, illicit drugs, alcohol) or are current abusers (using definition criteria from the Diagnostic and...
- people who have major psychiatric disorders, such as major depression, bipolar disorder and schizophrenia, as defined by the DSM-V
- If female, people 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
- people having participated in any other clinical study within the last three (3) months, or are actively participating in any other clinical study, or have planned participation in any other clinical study during the...
- Body Mass Index (BMI) \>35 kg/m2
- Current smoker or nicotine and/or tobacco user
- Known allergy or hypersensitivity to any of the device materials
- Endocrine or metabolic disorder known to affect osteogenesis
- Insulin-dependent diabetes mellitus
- Inability to undergo X-ray, MRI, CT 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 how well it works...
- people 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
- Evidence of 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Santa Monica, California, United States
- Walnut Creek, California, United States
- Greenwood Village, Colorado, United States
- Gainesville, Florida, United States
- Port Charlotte, Florida, United States
- Riverview, Florida, United States
- Jasper, Georgia, United States
- Overland Park, Kansas, United States
- Shreveport, Louisiana, United States
- Edmond, Oklahoma, United States
- Tyler, Texas, United States
- Richmond, Virginia, United States
- Calgary, Alberta, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Santa Monica, California, United States; Walnut Creek, California, United States; Greenwood Village, Colorado, United States; Gainesville, Florida, United States; Port Charlotte, Florida, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.