An interventional study of PerQdisc® Nucleus Replacement Device. in Degenerative Disc Disease and Chronic Low-back Pain, sponsored by Spinal Stabilization Technologies. Terminated at 4 sites in 4 countries. Open to participants aged 22 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Spinal Stabilization Technologies · Not applicable, Interventional, and Treatment
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain by maintaining disc height while preserving range of motion.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 9 is below the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Spinal Stabilization Technologies is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intraoperative exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
Device: PerQdisc® Nucleus Replacement Device.
All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
Rate of revision surgery at the treated level
Number of patients requiring surgeries to revise the implanted level in the spine divided by the total number of implant surgeries. Express in percentage (0-100)
Time frame: 90 days
Rate of expulsion
The rate of device expulsion. The number of patients determined to have expulsed devices divided by the total number of patients receiving implants.Expressed in percentage (0-100)
Time frame: 90 Days
Rate of new herniation at the treated level as determined by MRI
Herniation will be determine by MRI. A herniation will be defined as violation of the intervertebral annulus, including expulsion of nucleus material. The response will be yes/no as assessed by the radiologist. Rate will be determined by total number of herniations divided by the total number of implanted devices. Expressed in percentage (0-100)
Time frame: 90 days
Rate of new radiculopathy
New complaint of leg pain will be recorded as a yes/no response. Any complaint of new radiculopathy not seen preoperatively. Expressed as total number of new radiculopathy complaints divided by total number of patients. Expressed in percentage (0-100)
Time frame: 90 days
MRI assessment of the endplate Modic changes.
Changes to vertebral endplates will be assigned based on Modic classification of I,II or III comparing preoperative grade to grade at 90 days. Possible scores are I,II or III
Time frame: 90 days
Rate of surgical procedure technical success
The number of devices successfully implanted divided by the number of successfully devices implanted + unsuccessful implants. Output will be in percentage (0-100)
Time frame: 90 days
Improvement in degree of disability as measured by the Oswestry Disability Index (ODI)
Change in absolute Oswestry Index score at 90 days compared to the preoperative score, range is 0-100
Time frame: 90 days
Improvement in back pain as measured by 10-centimeter Visual Analog Scale (VAS)
Change in the Visual Analogue Scale (VAS) for back and leg pain on a scale of 0-10 cm comparing preoperative scores to 90 days post-operative.
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2019 to primary completion in Mar 2022, 36 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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