New disc implant could ease back pain without fusion
NCT ID NCT06860867
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new artificial disc called PerQdisc in 5 people with chronic back pain from a single damaged disc. The implant aims to replace the painful disc and improve pain and function. Researchers are checking if it is safe and works well enough to study further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PerQdisc artificial implant (a device placed in the spine to replace a damaged disc)
- What this could lead to
- If it works, this could point toward a new treatment option for chronic back pain caused by a damaged disc, potentially reducing pain and improving function without fusion surgery.
- What could go wrong
- This is a very early feasibility trial with only 5 participants, so results may not apply to everyone. The implant is new, and risks like device failure or worsening pain are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Skeletally mature male or female subjects aged 22-70 (inclusive). 2. Subject has a primary diagnosis of single level discogenic back pain caused by degenerative disc disease (L1 to L5) identified via MRI. 3. Subject has an intact annulus (as determined by MRI) and endplates (as determined by MRI and X-ray) at the level to be treated. 4. Subject must have failed to respond to a minimum of 6 months of conservative treatment for their back pain (e.g., physical therapy, medications, injections, ablations, lifestyle changes, etc.). 5. Subject has a low back pain VAS ≥40 mm (4 cm). 6. Subject has adequate disc height (≥6mm measured at the center of the disc) at the level to be treated. \[As measured by the investigator\] 7. Subject is 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. 8. Subject has read and understands the IRB approved informed consent document prior to signing and dating the document and before the initiation of any study-related procedures 9. Subject is appropriate candidate for the PerQdisc surgical approach \[as defined in the surgical technique guide\]. Exclusion Criteria: 1. Subject has symptomatic degenerative disc disease at more than one lumbar level 2. Subject has had a prior spinal fusion in the lumbar or thoracic intervertebral spaces. 3. Subject has had a prior SI-joint fusion. 4. Subject has a spinal cord stimulator. 5. Subject has had any prior lumbar spine surgery (instrumented or non-instrumented) 6. Subject has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion. 7. Subject has congenital moderate or severe spinal stenosis or epidural lipomatosis. 8. Subject has spondylolisthesis (antero- or retrolisthesis) in static X-ray ≥3 mm \[measured via neutral lateral x-ray\] 9. Subject has ≥4 mm dynamic spondylolisthesis \[measured via flexion/extension x-rays\] 10. Subject has \> 20 degree range of motion at the index level \[measured via flexion/extension x-rays\] 11. Subject has a history of any invasive malignancy (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors). 12. Subject has an active systemic infection or infection at the operative site. 13. Subject has evidence of symptomatic facet joint degeneration or disease where the investigator feels the facet is a major contributor to the subject's pain as diagnosed by injection and/or imaging. 14. Subject has a known allergy to silicone or barium sulfate. 15. Subject has been diagnosed with fibromyalgia, hepatitis, rheumatoid arthritis, lupus erythematosus, AIDs, ARC, HIV, or an autoimmune disease that affects the musculoskeletal system. 16. Subject has been diagnosed with Paget's disease, osteomalacia or any other metabolic bone disease. 17. Subject has current or recent history (defined ≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) using standard medical definitions of DSM-5 18. Subject has morbid obesity defined as a body mass index (BMI) \> 40. 19. Subject participated in an investigational drug or another medical device study within the last 30 days prior to surgery. 20. Subject has Osteoporosis, defined as a T-score ≤ -2.5. 1. An existing DEXA is allowed if completed within 6 months of subject surgery. 2. For all subjects without an existing DEXA, 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. 21. Female subjects who are pregnant or are trying to become pregnant during the course of the trial. 22. Subject has diabetes mellitus (Type 1 or 2) requiring daily insulin management. 23. Subject belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser) 24. Subject is currently receiving worker's compensation or is involved in any litigation for medical negligence, trauma, or worker's compensation. 25. Subject has lumbar scoliosis \> 10 degrees at index level. 26. Subject has a large, rectangular or irregularly shaped Schmorl's node with an associated active inflammatory process (Modic I changes). 27. Subject has motion of \< 3 degrees on pre-operative lateral flexion/extension radiographs at index level. 28. Subject has opioid medication usage \> 60 MME (morphine milligram equivalent)/day or change in opioid prescription within 60 days of surgery. 29. Subject has a preoperative VAS right or left leg pain score \> the preoperative VAS Back score. 30. Subject has a history of vertebral fractures in the lumbar spine. 31. Subject has evidence of severe compression of cauda equina. 32. Subject is on chronic anticoagulation therapy due to a bleeding disorder and is unable to safely stop anticoagulants or has taken anticoagulants within 3 days prior to procedure. 33. Subject has low back pain (LBP) of non-spinal or unknown etiology. 34. Subject is unable to undergo X-ray, MRI, or other radiographic assessments, including discography. 35. Subject has a degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to spinal disease (not at index level), Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis. 36. Subject has, in the opinion of the investigator, a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device. 37. In the opinion of the investigator the subject has a major psychiatric disorder that may interfere with the assessment of the safety or effectiveness of the device. 38. Subject has myelopathy. 39. Subject has primarily leg pain with associated nerve root compression, in the opinion of the investigator. 40. Subject has an annular defect greater than 6mm that extends from the interior of the disc to the outer margin of the annulus as evaluated on MRI.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Axis Spine Center
RECRUITINGCoeur d'Alene, Idaho, 83854, United States
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HOPE Research Institute
WITHDRAWNPhoenix, Arizona, 85032, United States
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HonorHealth Research & Innovation Institute
RECRUITINGScottsdale, Arizona, 85251, United States
Contact Email: •••••@•••••
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Hope Research Institute
WITHDRAWNGlendale, Arizona, 85308, United States
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Indiana Spine Group
RECRUITINGCarmel, Indiana, 46032, United States
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SonoSpine
WITHDRAWNOklahoma City, Oklahoma, 73159, United States
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Spine Institute of Louisiana
RECRUITINGShreveport, Louisiana, 71101, United States
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The CORE Institute
RECRUITINGPhoenix, Arizona, 85023, United States
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