An observational study in Degenerative Disc Disease and Chronic Low-back Pain, sponsored by Spinal Stabilization Technologies. Withdrawn at 1 site in Germany. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Spinal Stabilization Technologies · Observational
PerQdisc PMCF1 is a post-market clinical follow-up observational trial to follow subjects receiving a PerQdisc spinal implant for a duration of 5 years.
This study will be a prospective, open-label, multi-center post-market observational study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System. Primary endpoints will be used to assess the safety and efficacy of the PerQdisc device.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
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.
Skeletally mature patients, age 21-60 years, with chronic low back pain of discogenic origin that is non-responsive to conservative, non-surgical therapy.
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:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Patient is skeletally mature and between 21 and 60 years of age. Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but must have a single level identified as the pain generator. Patient has adequate disc height (6mm) at the level to be treated Patient is not responsive to conservative, non-surgical treatment for back pain.
Drug: PerQdisc
Observational trial to collect post-market safety and efficacy information in a limited number of human patients
Also known as: PerQdisc Nucleus Replacement System
PerQdisc Perfomance
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Time frame: 6 months post implant
PerQdisc Perfomance
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Time frame: 12 months post implant
PerQdisc Safety
Incidence of device expulsion and device fracture following surgery based on follow up X-rays and MRI's
Time frame: 6 months post implant
PerQdisc Safety
Incidence of device expulsion and device fracture following surgery based on follow up x-rays and MRI's
Time frame: 12 months post implant
Incidence of Secondary Surgeries
Incidence of revision surgery at the index level or other secondary lumbar surgery at a non-index level
Time frame: 6 months, 12 months, and 5 years following surgery
Maintenance of Disc Height
Intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline
Time frame: 6 months, 12 months, and 5 years following surgery
Maintenance of Range of Motion
Measurement of range of motion (expressed in degrees) at the index and adjacent levels at baseline compared to post-surgical follow-up using flexion/extension x-rays.
Time frame: 6 months, 12 months, and 5 years following surgery
Maintenance of Neurologic Status
Physical assessment evaluating nerve compression at baseline and post-surgical follow up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale.
Time frame: 6 months, 12 months, and 5 years following surgery
Use of Pain Medications
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale ranging from 0 to 4. 0 (no meds) to 4 (high dose opioids)
Time frame: 6 months, 12 months, and 5 years following surgery
Plan to share: Yes — De-identified outcome data will be available to participating investigators
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available 1 year after the final patient has completed one-year follow-up. Additional data will be available after the final patient has completed 5 year follow up
Access criteria: Data will be shared with investigators from a secure electronic database
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Dec 2021, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →
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