PerQdisc for Low Back Pain

Recruiting at 4 trial locations

Overseen By Molly Bond

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spinal Stabilization Technologies

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Diabetes, Obesity, Osteoporosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of the PerQdisc device for individuals with low back pain. The PerQdisc is a new implant designed to replace part of a damaged spinal disc, helping to relieve pain and maintain movement. It may suit those who have experienced low back pain from a single damaged disc for at least six months and have not found relief with treatments like physical therapy or medications. Participants will know their treatment and will be monitored to ensure safety and effectiveness. As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options for low back pain.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on opioid medication, you must not exceed 60 MME (morphine milligram equivalent) per day or have any changes in your opioid prescription within 60 days of surgery.

What prior data suggests that the PerQdisc device is safe for treating low back pain?

Research shows that the PerQdisc device is being tested to help with chronic low back pain. Earlier studies have gathered safety information about this device and found that most people tolerated the PerQdisc well. Some patients experienced minor side effects, but serious problems were uncommon. The PerQdisc is a new implant that replaces part of the spine's disc to reduce pain and allow movement. This background suggests that the device is reasonably safe based on earlier trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for low back pain, which often involve pain medications or invasive surgeries like spinal fusion, the PerQdisc offers a novel approach by preserving spinal motion. It replaces the damaged nucleus pulposus with a silicone membrane that is filled in situ and cures to conform to the space, providing a customized fit. This innovative method is designed to alleviate pain while maintaining the natural movement of the spine, which is a major advancement over more rigid surgical options. Researchers are excited about this treatment because it offers the potential for faster recovery and less disruption to the spine's natural mechanics.

What evidence suggests that the PerQdisc is effective for low back pain?

Research has shown that the PerQdisc device, which participants in this trial will receive, can help treat low back pain. In earlier studies, more than 87% of patients who underwent disc replacement surgery, similar to the PerQdisc procedure, experienced significant pain relief. One study found that 52.3% of patients reported no pain, while 33.07% experienced only slight discomfort after the procedure. The PerQdisc replaces the damaged part of a spinal disc with a silicone implant, maintaining spinal movement and reducing pain. These findings suggest that the PerQdisc could be a promising option for individuals with persistent low back pain. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing back pain, specifically discogenic low back pain. Participants should be suitable candidates for the PerQdisc treatment based on a screening process. Details about specific inclusion and exclusion criteria are not provided, but typically these would outline health conditions or factors that qualify or disqualify someone from participating.

Inclusion Criteria

Subject has read and understands the IRB approved informed consent document prior to signing and dating the document

My back pain hasn't improved after 6 months of standard treatment.

I am a suitable candidate for PerQdisc surgery.

Exclusion Criteria

Subject has a spinal cord stimulator

I am on long-term blood thinner medication.

I have had spinal fusion surgery in my back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the PerQdisc device to evaluate its safety and effectiveness

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PerQdisc

Trial Overview The trial is testing the safety and effectiveness of a device called PerQdisc in treating discogenic low back pain. It's a prospective study, meaning it follows patients over time, conducted across multiple centers, and open label so participants know they're receiving the PerQdisc treatment.

How Is the Trial Designed?

Group I: PerQdisc Experimental Treatment 1 Intervention

The PerQdisc device is the first in a new category of contained in-situ filled and then cured lumbar spinal implant. The PerQdisc is intended to replace the nucleus pulposus in a single lumbar disc level, preserve motion and alleviate pain. The PerQdisc is a silicone membrane (barrier membrane) configured to be filled with a room temperature vulcanizing silicone (RTVS) that will cure within minutes, resulting in a final shape that conforms to the nucleus space created by the surgical removal of the diseased or damaged nucleus pulposus.

Who Is Running the Clinical Trial?

Spinal Stabilization Technologies

Lead Sponsor

Trials

6

Recruited

220+

Published Research Related to This Trial

In a study of 29 patients with degenerative disc disease who did not respond to conservative treatments, percutaneous intradiscal GelStix administration significantly reduced pain levels, with mean visual analogue scale (VAS) scores dropping from 7.14 to 2.48 over 12 months (P < 0.001).

Patients also experienced improved functionality, as indicated by a decrease in the Oswestry Disability Index (ODI) scores from 28.14 to 17.35, and 86.2% reported satisfaction with the procedure at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results of intradiscal hydrogel administration (GelStix) in lumbar degenerative disc disease Ceylan, A., Aşik, I., Özgencil, GE., et al.[2020]

Conservative therapy, including non-steroidal anti-inflammatory drugs (NSAIDs) like piroxicam, indomethacin, and diclofenac, is effective for treating acute low back pain, with studies showing these medications have nearly identical efficacy.

Intramuscular piroxicam (40 mg for two days, then 20 mg) provided effective pain relief and was well-tolerated compared to higher doses of ketoprofen and diclofenac, suggesting it may be a preferable option for managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low back pain. Simon, L.[2013]

Most monotherapies for chronic low back pain, such as analgesics and physiotherapy, have limited effectiveness, while multidisciplinary therapy focusing on intensive exercises shows modest improvements in physical function and pain relief.

Specific diagnostic techniques like joint blocks can identify pain sources in a significant number of patients, and treatments like radiofrequency neurotomy can effectively relieve zygapophysial joint pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic low back pain. Bogduk, N.[2022]

Intradiscal electrothermal therapy (IDET) is a promising minimally invasive treatment for internal disc disruption (IDD) in patients with low back pain, offering a potential alternative to traditional conservative or surgical options.

The effectiveness of IDET appears to be significant in carefully selected patients, but further research with long-term follow-up is needed to fully establish its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intradiscal electrothermal therapy (IDET)]. Münnich, U., Kreckel, V., Koy, T., et al.[2016]

In a study involving 20 patients with chronic low back pain due to degenerative disc disease, the use of intradiscal hydrogel showed significant effectiveness, reducing pain scores from a median of 7 to 1 and improving disability scores significantly over a follow-up period of 6 months.

The treatment was deemed safe, with only 5 serious adverse events reported, 4 of which were associated with the treatment, but no persistently symptomatic adverse effects were noted, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydrogel Augmentation of the Lumbar Intervertebral Disc: An Early Feasibility Study of a Treatment for Discogenic Low Back Pain. Beall, DP., Amirdelfan, K., Nunley, PD., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9469036/

Long-Term Outcomes Following Lumbar Nucleus Replacement Twenty-six patients received DASCOR implants between January 2006 and November 2009. Three patients were lost to follow-up and 1 patient had ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04141098

Lumbar Operatively Inserted PerQdisc Artificial Implant ... This study will be a prospective, open-label, multi-center study that will collect safety and efficacy data for the minimally invasive PerQdisc Nucleus ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666548425002331

Long-Term Outcomes of Total Lumbar Disc Prosthesis At final follow-up, 52.3% of patients reported complete resolution of pain, while an additional 33.07% experienced only minimal discomfort (VAS ...

4. sstspine.com sstspine.com/clinical-trials

Clinical Trials LOPAIN1 is a clinical trial designed to study the safety and efficacy of the PerQdisc device in patients suffering from chronic low back pain.

5. cuellarspine.com cuellarspine.com/insights/success-rate-of-artificial-disc-replacement/

Benefits & Success Rate of Artificial Disc Replacement The FDA's clinical trial data also showed that people who underwent disc replacement surgery had a success rate of over 87% compared with 81% of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04004156

NCT04004156 | Safety Study for An Artificial Disc Nucleus ... This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device ( ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05508360/lumbar-operatively-inserted-perqdisc-artificial-implant-following-nulcectomy-lopain2

"Lumbar Operatively Inserted PerQdisc Artificial Implant ... This study will be a prospective, open-label, multi-center study that will collect additional safety and efficacy data for the minimally invasive PerQdisc ...

8. perqdisc.com perqdisc.com/

PerQdisc: Homepage Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc). LOPAIN3 is a clinical trial designed to gather clinical data on the feasibility, safety, ...