HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs (HYDRAFIL-D)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Disc Disease (DDD)
• Intervention / Treatment: Device: The ReGelTec HYDRAFIL™ System; Other: Conservative Care Management

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Townsend; Phone Number: 443-451-3915
• Study Contact Backup: Name: Elisa B Storyk, MPH, CCRP; Phone Number: 443-451-3915

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subjects aged 22 to 85 years, inclusive
• Subjects 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

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 increase in opioid use within 60 days of enrollment
• Evidence of 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. Note: somatic referred pain is allowed
• Evidence of neurogenic claudication due to spinal stenosis
• Subjects 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)]
• Subjects with arachnoiditis
• Subjects who are prisoners or wards of courts
• Subjects involved in active litigation including worker's compensation cases
• Subjects 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
• Subjects with LBP of non-spinal or unknown etiology
• Subjects 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 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
• Subjects 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 course of this trial. Note: subjects must agree they will not participate in any other clinical study during the course of this trial
• 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 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
• Evidence of severe osteoporosis. The FRAX will be utilized to screen if a DEXA scan is indicated. If the subject's 10-year probability of any major osteoporotic fracture according to FRAX is at least 20% or a hip fracture risk of 3% or more, then a DEXA scan is required. Severe osteoporosis is defined by the threshold of bone density value below the -2.5 SDs of T-score, determined by DEXA, and the presence of one or more fragility fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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; The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.; Other: Conservative Care Management; Conservative care management (including physical therapy and/or pain medication); Other Names: Non-surgical conservative medical management
Sham Comparator: Control Arm; Group B: continued non-surgical conservative medical management plus advancement of the HYDRAFIL System delivery needle to inside the skin in the direction of the target disc(s) but without contacting the muscle layer or deeper (the "Control Arm")	Other: Conservative Care Management; Conservative care management (including physical therapy and/or pain medication); Other Names: Non-surgical conservative medical management

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ReGelTec, Inc.
• Investigators: Principal Investigator: Douglas Beall, MD, Clinical Investigations LLC; Principal Investigator: Kasra Amirdelfan, MD, IPM Medical Group

Publications and helpful links

Helpful Links

• Sponsor Company Website

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Estimated): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Nucleus Pulposus; Intervertebral Disc; Disc Augmentation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: RGT-2000PS

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: Yes