HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 21
- 主要终点
- Composite Endpoint of Clinical Success
研究概览
简要总结
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single-blind (participants will be blinded to treatment assignment)
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 randomization
- •Opioid medication usage >60 MME (morphine milligram equivalent)/day or increase in opioid use within 60 days of randomization
- •Evidence of Modic type 3 changes at the symptomatic level(s) or on adjacent levels
- •Subjects presenting with nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging where lower limb pain is greater than back pain or by history within the past six (6) months. Note: somatic referred pain is allowed
- •Evidence of neurogenic claudication due to spinal stenosis
- •Subjects having had any prior lumbar spine surgery (instrumented or non-instrumented) except: a. A non-instrumented procedure not at the symptomatic or adjacent levels (i.e., discectomy, laminectomy, MILD procedure) is not exclusionary if the procedure was completed at least one (1) year or greater from randomization with complete resolution of treated symptoms and no recurrence
- •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 who have participated in any other clinical study within the last three (3) months that, in the opinion of the investigator, could bias the results of the HYDRAFIL-D study, or subjects that 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) >40 kg/m2
- •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 SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/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
研究组 & 干预措施
Crossover After 24M for Control Patient if Qualified
Study design includes a crossover for control arm after 24 months if qualified after a screening evaluation
干预措施: The ReGelTec HYDRAFIL™ System (Device)
Crossover After 24M for Control Patient if Qualified
Study design includes a crossover for control arm after 24 months if qualified after a screening evaluation
干预措施: Conservative Care Management (Other)
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")
干预措施: Conservative Care Management (Other)
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")
干预措施: Conservative Care Management (Other)
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")
干预措施: The ReGelTec HYDRAFIL™ System (Device)
结局指标
主要结局
Composite Endpoint of Clinical Success
时间窗: 12-month
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.
次要结局
未报告次要终点