Study of the ReGelTec HYDRAFIL System

ReGelTec

Status

Active, not recruiting

Conditions

Degenerative Disc Disease

Treatments

Device: HYDRAFIL

Study type

Interventional

Funder types

Industry

Identifiers

NCT04984629

RGOUS -1000CAN

Details and patient eligibility

About

A study designed to treat patients with back pain associated with degenerative lumbar disc disease.

Full description

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

The primary objective of this study is to evaluate the safety and efficacy the HYDRAFIL System.

Enrollment

35 patients

Sex

All

Ages

22 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Present with predominant low back pain and symptoms of DDD of the lumbar region of at least 6 months duration
Failure to have their symptoms resolve or reduce following 6 months conservative care (pain medication and/or physical therapy)
Male or female patients aged 22 to 80 years, inclusive
Presence of DDD on magnetic resonance imaging (MRI) scan with global disc degeneration. Modified Pfirrmann grades 5 to 8 as characterized by MRI
The presence of one or two symptomatic discs exhibiting degeneration contained within a competent outer annulus as determined by MRI and provocative discography and/or anaesthetic discography at L1-S1
Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation
Signed an informed subject consent form in a language in which they are fluent

Exclusion criteria

History of or current systemic or local infection
Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography
Presence of disc herniation that accounts for the majority of the patient's symptoms
Subjects with Modic type 3 changes
Subjects with trans-endplate disc herniations or Schmorl's nodes
Neurogenic claudication due to spinal stenosis
Previous back surgery at the target level of the lumbar spine
Evidence of severe compression of cauda equina
Spinal segmental instability (spondylolysis or spondylolisthesis: Grade >1), spinal canal stenosis, isthmus pathology, scoliosis [Cobb angle >20 at the incident level] and other deformity conditions that may compromise the study
Subjects with arachnoiditis
Subjects who are prisoners or wards of the courts
Subjects involved in active litigation including worker's compensation cases
Subjects with low back pain of non-spinal or unknown etiology
Subjects with severe osteoporosis or metabolic bone disease
Subjects who have a history of or are current abusers of alcohol or drugs (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V))
If female, patients 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 participation in any other clinical study
Body Mass index (BMI) greater than 40
Patients with active tumors in the spinal region
Patients who have been diagnosed to diabetes mellitus
Patients who have a sensitivity or allergy to the implant materials