HYDRAFIL for Degenerative Disc Disease
(HYDRAFIL-D Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: ReGelTec, Inc.
Must not be taking: Opioids, Anticoagulants
Disqualifiers: Infection, Disc herniation, Prior surgery, Psychiatric disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had an epidural steroid injection, intradiscal injection, or certain other injections within 60 days before joining. Also, if you are on opioids, you must not exceed 60 MME (morphine milligram equivalent) per day or have increased your dose in the last 60 days.
Is HYDRAFIL safe for humans?
The safety data for HYDRAFIL specifically is not available, but similar products like hyaluronic acid fillers are generally considered safe, with most side effects being mild or moderate and temporary. However, as with any medical procedure, there can be severe adverse events, so it's important to be informed of potential risks.
12345How is the HYDRAFIL treatment different from other treatments for degenerative disc disease?
The HYDRAFIL treatment is unique because it involves a minimally invasive approach using a gel-like substance to restore disc function, which differs from traditional surgical methods like discectomy or spinal fusion. This approach aims to maintain disc height and flexibility, offering a potential alternative to more invasive procedures.
678910Eligibility Criteria
This trial is for men and women aged 22-85 with lower back pain due to degenerative disc disease, confirmed by MRI and discography. Participants must have tried conservative care for six months without relief, be able to follow the study's procedures, complete forms, and speak English fluently.Inclusion Criteria
My MRI shows I have moderate to severe disc degeneration.
My symptoms didn't improve after 6 months of standard treatment.
You are capable of completing the requirements and participating in this protocol, both mentally and physically.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the HYDRAFIL implant or a sham procedure as part of the study
6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Participant Groups
The HYDRAFIL-D trial is testing the ReGelTec HYDRAFIL™ System against standard conservative care management in patients with degenerative disc disease. It's a multi-center study where participants are randomly assigned to one of these two approaches.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment2 Interventions
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")
Group II: Control ArmPlacebo Group1 Intervention
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")
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boomerang HealthcareWalnut Creek, CA
Clinical InvestigationsEdmond, OK
Precision Spine CareTyler, TX
Boomerang Healthcare (IPM Medical Group)Walnut Creek, CA
More Trial Locations
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Who Is Running the Clinical Trial?
ReGelTec, Inc.Lead Sponsor
References
Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients. [2021]Recent publications have suggested an increased risk of delayed adverse events (DAEs) with a smooth, cohesive 20-mg/mL hyaluronic acid filler, Juvéderm Voluma (HA-V).
Transvascular Hydrolysis of Hyaluronic Acid Filler With Hyaluronidase: An Ex Vivo Study. [2021]Despite the favorable safety profile of hyaluronic acid (HA) dermal fillers, side effects can occur. Skin necrosis is one of the most severe early-occurring complications resulting from accidental vascular impairment. Hyaluronidase (HYAL) is commonly used to degrade HA chains, allowing the degraded product to pass through vessels, and thus relieving the vascular obstruction.
Learning curves: historical trends of FDA-reported adverse events for dermal fillers. [2019]Dermal fillers are medical devices regulated by the US Food and Drug Administration (FDA); therefore, reported adverse events (AEs) are publicly available via OpenFDA. Evaluation of historical AE data trends may help distinguish between AEs related to expected learning curves associated with a new type of filler from AEs related to inherent characteristics of a product. In this study, the full history of AE data was evaluated to establish reproducible learning curves for FDA-approved dermal fillers. Reactions to AEs for new fillers that garner FDA approval or are awarded new indications should be in response to analysis of AE rate data and determination of whether they fit on a historically normal learning curve.
Consensus statement on prevention and management of adverse effects following rejuvenation procedures with hyaluronic acid-based fillers. [2022]Facial fillers play an important role in the correction of facial changes associated with ageing. They offer quick treatments in the outpatient setting with minimal subsequent downtime that provide predictable, natural-looking, long-lasting results. Adverse reactions after hyaluronic acid injections tend to be mild or moderate and rather temporary. However, as with all injected or implanted biomaterials, severe adverse events can occur and patients must be fully informed of potential risks prior to undergoing treatment. A panel of experts from Germany (D), Austria (A) and Switzerland (CH) developed recommendations, and this study provides the 'DACH Consensus Recommendations' from this group specifically on the use of hyaluronic acid fillers. The aim is to help clinicians recognize potential risks and to provide guidance on how best to treat adverse events if they arise. Contraindications to hyaluronic acid fillers are also detailed, and ways to prevent adverse events occurring are discussed. Hyaluronic acid-based products are claimed to be very close to an ideal tissue augmentation agent; nevertheless, profound medical, anatomical and product knowledge are of paramount importance to minimize the occurrence of adverse reactions.
A problem-oriented approach to nodular complications from hyaluronic acid and calcium hydroxylapatite fillers: classification and recommendations for treatment. [2021]Hyaluronic acid and calcium hydroxylapatite fillers are generally safe, efficacious, and well tolerated. However, complications are inevitable, as with any medical procedure. Nodules at the site of filler implantation may pose the greatest challenge, as treatment is often empiric and can be influenced by misconceptions.
Biologic therapies to enhance intervertebral disc repair. [2018]Degenerative disc disease is a progressive, chronic disorder with strong association to pain, where the dysregulated tissue environment signals disc cells, thereby leading to a low inflammatory process and slow extracellular matrix degradation and fibrosis in a perpetual vicious cycle, generating a structural and functional failure of intervertebral disc joint (IVDJ). Among current biologic therapies, there is an emerging minimally invasive strategy that consists of infiltrating plasma rich in growth factors, a safe and efficacious therapeutic approach for other musculoskeletal degenerative conditions. This review summarizes the homeostasis and degeneration of IVDJ, discusses some results on basic science and therapeutic use of platelet-rich plasma products and advances an alternative minimally invasive biologic therapy in IVDJ degeneration and chronic back pain.
Regenerative Medicine Modalities for the Treatment of Degenerative Disk Disease. [2022]Degenerative disk disease is a pathologic state associated with axial skeletal pain, radiculopathy, and myelopathy, and will inevitably increase in prevalence in parallel with an aging population. The objective of regenerative medicine is to convert the inflammatory, catabolic microenvironment of degenerative disease into an anti-inflammatory, anabolic environment. This comprehensive review discusses and outlines both in vitro and in vivo efficacy of regenerative treatment modalities for degenerative disk disease, such as; mesenchymal stem cells, gene therapy, tissue engineering, and biologic treatments. To date, clinical applications have been limited secondary to a lack of standardized high quality clinical data. Additional research should focus on determining the optimal cellular makeup and concentration for each of these interventions. Nevertheless, modern medicine provides a new avenue of confronting disease, with methods surpassing traditional methods of removing the pathology in question, as regenerative medicine provides the opportunity to recover from the diseased state.
The PDN prosthetic disc-nucleus device. [2013]The health of an intervertebral disc is based on a complicated interplay between physiology and biomechanics. The nucleus pulposus must remain well hydrated, and the surrounding anulus fibrosus must be competent in order for the disc to function properly. If either of these components fail, the disc will begin to degenerate, and clinically relevant symptoms may appear. Disc degeneration has traditionally been treated by either discectomy or immobilization of the affected vertebrae, and though these treatments can be effective, they also have their limitations. To help fill the therapy gap that exists for treating moderate degenerative disc disease, the PDN device has been developed. The device consists of a hydrogel core and a polyethylene jacket that are designed to assume the cushioning function of a healthy disc, while restoring/maintaining disc height and allowing normal range of motion. To receive the device, patients must have a preoperative disc height of at least 5 mm and the vertebral endplates must be free of significant defects such as Schmorl's nodules or fractures. Two approaches can be used for implanting PDN devices: a hemilaminotomy approach, where the disc is accessed through the back, or an Anterior-Lateral transPsoatic Approach (ALPA), where the disc is accessed from the side. In either case, the nucleus material is removed from the disc, and the devices are placed transversely within the nucleus cavity. The amount of research and development currently taking place in the field of disc arthroplasty gives hope that the treatment of degenerative disc disease will soon become multifaceted, with numerous choices being available to surgeons and their patients.
Lumbar disc rehydration postimplantation of a posterior dynamic stabilization system. [2016]Biological attempts at disc regeneration are promising; however, disc degeneration is closely related to other predisposing factors such as alteration of disc height, intradiscal pressure, load distribution, and motion. The restoration of the physiological status of the affected spinal segment is thus necessary prior to attempts at disc regeneration. Dynamic stabilization systems now offer the potential of a mechanical approach to intervertebral disc regeneration. The authors used decompression and placement of the BioFlex dynamic stabilization device to treat a young male patient with disc degeneration. This patient underwent follow-up, and he was found to gradually improve both neurologically and radiographically. On MR imaging performed 1 year postoperatively, he had an increase in disc height and disc rehydration. This case and the concept of disc rehydration are presented in this paper.
Efficacy of DiscoGel in Treatment of Degenerative Disc Disease: A Prospective 1-Year Observation of 67 Patients. [2023]Patients with degenerative disc disease may suffer from chronic lumbar discogenic (DP) or radicular leg (RLP) pain. Minimally invasive DiscoGel therapy involves the percutaneous injection of an ethanol gel into the degenerated disk's nucleus pulposus. This paper compares the 1-year outcome of such treatment in DP and RLP patients. We operated on 67 patients (49 men and 18 women) aged 20-68 years (mean age 46 ± 11 years) with DP (n = 45) and RLP (n = 22), of at least 6-8 weeks duration, with no adverse effects. We evaluated the treatment outcome with Core Outcome Measures Index (COMI) and Visual Analog Scale (VAS). A year after the ethanol gel injection, in the DP cohort, COMI and VAS dropped by 66% (6.40 vs. 2.20) and 53% (6.33 vs. 2.97), respectively. For the RLP patients, the corresponding values dropped 48% (7.05 vs. 3.68) and 54% (6.77 vs. 3.13). There were no differences between the cohorts in COMI and VAS at the follow-up end. Six months into the study, 74% of DP and 81% of RLP patients did not use any analgesics. Ethanol gel therapy can be effective for many patients. Moreover, its potential failure does not exclude surgical treatment options.