Interspinous Fusion for Lower Back Pain

(Refine Trial)

Recruiting at 10 trial locations

Overseen By Michael Danko, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pacific Research Institute

Disqualifiers: Previous lumbar surgery, Osteoporosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Aurora Spine ZIP™ MIS Interspinous Fusion System to determine its effectiveness in alleviating chronic lower back pain from degenerative disc disease and neurogenic claudication (leg pain from nerve issues). The goal is to assess whether the device can safely reduce pain and improve function. Ideal candidates have experienced lower back pain for an extended period, tried non-surgical treatments for at least three months, and feel some relief when sitting or bending forward. As an unphased trial, this study provides patients an opportunity to contribute to innovative research that could lead to new treatment options for chronic lower back pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that the Aurora Spine ZIP™ MIS Interspinous Fusion System is safe for patients with chronic low back pain?

Research shows that lumbar interlaminar decompression with interspinous fixation effectively and safely treats spinal stenosis, a condition where spaces in the spine narrow. The Aurora Spine ZIP™ MIS Interspinous Fusion System, a type of interspinous fixation, has shown promise in treating this condition.

This system offers a minimally invasive option for spine surgery, using smaller incisions. It stabilizes the spine to relieve back pain. Reports have not identified major safety issues, indicating it is generally well-tolerated by patients.

Although specific data on side effects is limited, its widespread use in spinal procedures suggests it is generally safe. Serious safety concerns would likely prevent its use in medical practice.

Prospective trial participants should consult medical professionals to understand potential risks based on individual health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Aurora Spine ZIP™ MIS Interspinous Fusion System is unique because it offers a minimally invasive approach to treating lower back pain, which is different from traditional surgical options like spinal fusion. Most standard treatments involve more extensive surgery with longer recovery times. However, this system is designed to stabilize the spine through a small incision, potentially reducing recovery time and postoperative pain. Researchers are excited about this treatment because it provides an innovative way to achieve spinal fusion with less impact on the body, making it easier for patients to return to their daily activities.

What evidence suggests that the Aurora Spine ZIP™ MIS Interspinous Fusion System is effective for chronic low back pain?

Research on the Aurora Spine ZIP™ MIS Interspinous Fusion System shows promising results for treating chronic low back pain. Studies have shown that devices like the Aurora ZIP system effectively relieve pressure on the spine and improve stability. This can help reduce pain and enhance movement for people with worn-out spinal discs and leg pain caused by nerve issues. In this trial, participants will receive the ZIP device. A study with patients using the ZIP device found it effective and safe, with positive outcomes reported at a 3-month follow-up. These early findings suggest that this treatment could be a good option for those dealing with persistent back pain. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic low back pain due to degenerative disc disease and mild to moderate spinal stenosis, who've tried non-surgical treatments for at least 3 months. Candidates should find relief in lumbar flexion/sitting and have significant pain while standing or walking. Exclusions include previous surgery at the treatment level, severe spondylolisthesis, osteoporosis, participation in other trials that could affect results, and pregnancy.

Inclusion Criteria

Bending forward or sitting relieves my back pain.

I have lower back issues due to degenerative disease in 1-2 spots from T12 to S1, with or without a slight spine misalignment.

I experience significant back or leg pain when standing or walking.

Exclusion Criteria

Subject is pregnant or nursing.

Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.

I have been diagnosed with or suspected to have weak bones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material for single-level fusion

12 months

Regular follow-up visits at 3 and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain reduction and functional outcomes

12 months

Follow-up assessments at 3 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Aurora Spine ZIP™ MIS Interspinous Fusion System

Trial Overview The REFINE Study tests the Aurora Spine ZIP™ MIS Interspinous Fusion System with bone graft material on patients with lower back pain from spinal conditions. It aims to assess how effective and safe this fusion device is when treating chronic back pain associated with degenerative diseases of the spine.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

A Prospective, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain A Prospective, Observational, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain

Aurora Spine ZIP™ MIS Interspinous Fusion System is already approved in United States for the following indications:

Approved in United States as Aurora ZIP MIS Interspinous Fusion System for:

• Degenerative disc disease
• Spinal stenosis
• Spondylolisthesis
• Trauma (fracture or dislocation)
• Tumor

Who Is Running the Clinical Trial?

Pacific Research Institute

Lead Sponsor

Trials

2

Recruited

260+

Published Research Related to This Trial

Lumbar interspinous process spacers help stabilize the spine by limiting extension in affected segments while preserving normal spinal function and increasing the space in the spinal canal, which can relieve pressure on nerves.

Clinical and biomechanical studies show promising results for these spacers, indicating they effectively reduce disc loading without significantly impacting the motion or load on adjacent spinal segments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress of lumbar interspinous process spacer]. Xia, ZM., Ni, F., Shi, JQ., et al.[2013]

In a study of 16 patients with degenerative lumbar diseases, the combined use of an interspinous process fixation system and a rigid fixation system led to significant improvements in pain and functional scores after an average follow-up of 17.6 months.

This approach not only alleviated pain (with lumbar VAS scores improving from 4.5 to 1.9) but also preserved segmental range of motion, suggesting it may be a safer alternative to traditional multi-segment fusion techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Retrospective study of combined application of interspinous process fixation system and rigid fixation system for degenerative lumbar diseases]. Sun, HL., Li, CD., Liu, XY., et al.[2019]

The study demonstrated that a novel interspinous process spacer (IPS) can be safely and feasibly inserted and removed percutaneously in a porcine model, indicating its potential for minimally invasive surgery.

The spacer effectively prevented an increase in epidural pressure during lumbar extension, suggesting it could help alleviate symptoms in patients with posture-dependent lumbar spinal-canal stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of percutaneously insertable/removable interspinous process spacer for treatment of posture-dependent lumbar spinal-canal stenosis: preclinical feasibility study using porcine model. Nishida, K., Doita, M., Kakutani, K., et al.[2021]

The interspinous segmental spinal instrumentation (ISSI) method improves pullout strength by 47% compared to traditional wire fixation, enhancing the stability of spinal implants.

Early clinical results indicate that ISSI is effective for treating various spinal conditions, particularly idiopathic and congenital scoliosis, showing promising outcomes in initial patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interspinous process segmental spinal instrumentation. Drummond, D., Guadagni, J., Keene, JS., et al.[2019]

In a study of 55 adolescents who underwent spinal fusion surgery for idiopathic scoliosis, significant improvements in back pain and quality of life were observed at least 5 years post-surgery compared to untreated patients and healthy controls.

While the surgical group reported similar quality of life to healthy controls, their functional scores were lower, indicating that while surgery alleviates pain and improves self-image, it may not fully restore functional abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Back Pain and Quality of Life After Surgical Treatment for Adolescent Idiopathic Scoliosis at 5-Year Follow-up: Comparison with Healthy Controls and Patients with Untreated Idiopathic Scoliosis. Helenius, L., Diarbakerli, E., Grauers, A., et al.[2021]

The interspinous anchor (ISA) significantly enhances stability in lumbar spine fusion when used with anterior lumbar interbody fusion (ALIF), providing similar rigidity to traditional pedicle screw/rod systems based on tests conducted on seven human cadaveric specimens.

The ISA was particularly effective in limiting flexion and extension movements, reducing the range of motion to 25% of normal, and it also increased foraminal height, suggesting it could be a viable alternative to anterior plate fixation in spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanics of a lumbar interspinous anchor with anterior lumbar interbody fusion. Karahalios, DG., Kaibara, T., Porter, RW., et al.[2022]

In a study of 40 patients with degenerative disc disease, the addition of Wallis interspinous dynamic stabilization to posterior interbody fusion showed significantly better long-term outcomes in terms of pain relief and functional improvement compared to fusion alone after 3 years.

While both treatment methods provided effective decompression initially, the Wallis stabilization technique helped maintain intervertebral disc height and canal area over time, suggesting it may reduce adjacent segment degeneration following lumbar fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical application of Wallis interspinous dynamic stabilization in treating adjacent segment degeneration (ASD) after lumbar spinal fusion]. Xu, JP., Yi, HL., Li, M., et al.[2014]

Interspinous spacers resulted in significantly lower estimated blood loss and shorter operative times compared to posterior lumbar interbody fusion (PLIF), making them a safer surgical option for patients with degenerative lumbar spinal diseases.

Both surgical methods showed similar outcomes in terms of post-operative pain and disability scores, indicating that interspinous spacers can be an effective alternative to PLIF for select patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interspinous spacers versus posterior lumbar interbody fusion for degenerative lumbar spinal diseases: a meta-analysis of prospective studies. Cai, Y., Luo, J., Huang, J., et al.[2019]

In a study of 35 patients with risk factors for fragility fractures, the addition of spinoplasty (cement augmentation) during interspinous spacer implantation showed no intraprocedural complications and was safe for patients.

The use of spinoplasty significantly reduced the incidence of delayed spinous process fractures, with only 4 out of 16 patients experiencing fractures compared to none in the 19 patients who received spinoplasty, highlighting its effectiveness in preventing such complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior vertebral arch cement augmentation (spinoplasty) to prevent fracture of spinous processes after interspinous spacer implant. Bonaldi, G., Bertolini, G., Marrocu, A., et al.[2021]

Interspinous spacers, including Coflex, Wallis, DIAM, and X-STOP, provide similar biomechanical stability after implantation, effectively reducing extension motion to about 50% compared to intact lumbar spines, while maintaining similar motion in flexion, lateral bending, and axial rotation.

The intradiscal pressure after implantation is comparable to intact specimens during flexion, lateral bending, and axial rotation, but significantly lower during extension, indicating that while these devices stabilize the spine, they may limit certain movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biomechanics of interspinous spacers]. Wilke, HJ., Drumm, J., Häussler, K., et al.[2021]

In a study of 250 patients with moderate lumbar spinal stenosis, both the Superion and X-Stop interspinous spacers showed significant improvements in pain and function over 2 years, with similar outcomes for both devices.

Patient satisfaction scores and freedom from reoperation were comparable between the two groups, indicating that both interspinous spacers are effective and safe options for patients unresponsive to conservative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis. Patel, VV., Whang, PG., Haley, TR., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10697144/

Early Functional Outcomes in Low Back Pain Subjects with a ... The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment.

2. withpower.com withpower.com/trial/phase-spinal-stenosis-2-2021-a82fb

Interspinous Fusion for Lower Back Pain (Refine Trial) Research on interspinous spacers, like the Aurora ZIP system, shows they can effectively relieve pressure on the spine and improve stability, which may help ...

3. link.springer.com link.springer.com/article/10.1007/s40122-022-00447-0

REFINE Study | Pain and Therapy This study will evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in ...

4. aurora-spine.com aurora-spine.com/

Aurora Spine | Advanced Spine Surgery & Back Pain Solutions Aurora Spine develops minimally invasive, patient-centric implants and solutions for spine surgery, back pain relief, and SI joint treatment.

5. thespinemarketgroup.com thespinemarketgroup.com/aurora-spine-corporation-announces-positive-interim-results-from-clinical-study-using-zip-mis-interspinous-fusion-system/

Aurora Spine Corporation Announces Positive Interim ... The publication also demonstrated that the use of the ZIP device was both effective and safe at the 3-month follow-up. This study remains active ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221399.pdf

July 8, 2022 Aurora Spine, Inc. Justin Eggleton VP, Spine ... The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine ...