Interspinous Fusion for Lower Back Pain

(Refine Trial)

Recruiting at 9 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.

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 data supports the effectiveness of the treatment Aurora Spine ZIP™ MIS Interspinous Fusion System for lower back pain?

Research on interspinous spacers, like the Aurora ZIP system, shows they can effectively relieve pressure on the spine and improve stability, which may help with lower back pain. Studies on similar devices have shown positive results in maintaining spinal movement and reducing stress on the spine. ^{1 2 3 4 5}

Is the Aurora Spine ZIP™ MIS Interspinous Fusion System safe for humans?

The safety of interspinous devices, like the Aurora Spine ZIP™ MIS Interspinous Fusion System, has been studied in various contexts. Research shows that these devices are generally safe, providing stability to the spine and maintaining similar pressure levels in the spine as before surgery, with minimal increase in motion after repeated use. ^{2 6 7 8 9}

How is the Aurora Spine ZIP™ MIS Interspinous Fusion System treatment different from other treatments for lower back pain?

The Aurora Spine ZIP™ MIS Interspinous Fusion System is unique because it is a minimally invasive surgical option that involves placing a spacer between the bones in the spine to stabilize the area and promote fusion, unlike traditional surgeries that may require more extensive procedures. ^{2 5 9 10 11}

Eligibility Criteria

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.

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical application of Wallis interspinous dynamic stabilization in treating adjacent segment degeneration (ASD) after lumbar spinal fusion]. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Biomechanics of a lumbar interspinous anchor with anterior lumbar interbody fusion. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Interspinous spacers versus posterior lumbar interbody fusion for degenerative lumbar spinal diseases: a meta-analysis of prospective studies. [2019]

4. United States 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. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Progress of lumbar interspinous process spacer]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Interspinous process segmental spinal instrumentation. [2019]

7. China pubmed.ncbi.nlm.nih.gov

[Retrospective study of combined application of interspinous process fixation system and rigid fixation system for degenerative lumbar diseases]. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Biomechanics of interspinous spacers]. [2021]

9. England 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. [2022]

10. Germany 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Posterior vertebral arch cement augmentation (spinoplasty) to prevent fracture of spinous processes after interspinous spacer implant. [2021]