Degenerative Disc DiseasePMCF1NCT05105490
Post Market Observational Trial for the PerQdisc Nucleus Replacement Device
An observational study of Degenerative Disc Disease and Chronic Low-back Pain, run by Spinal Stabilization Technologies at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Degenerative Disc Disease, Chronic Low-back Pain
- What is being tested?
- PerQdisc
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 31 Dec 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Skeletally mature patients, age 21-60 years, with chronic low back pain of discogenic origin that is non-responsive to conservative, non-surgical therapy.
Who may be able to join
- 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.
- Patient has signed the approved Informed Consent Form.
Who cannot join
- Patient has less than 6 mm of disc height.
- Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
- Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.
- Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
- Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
- Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to Spine Intervention Society (SIS) guidelines (diagnostic, contrast controlled).
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- Patient has any known active malignancy.
- Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.
- Patient has active or local systemic infection.
- Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including Acquired Immune Deficiency Syndrome (AIDS), AIDS related Complex (ARC), and Human Immunodeficiency Virus (HIV).
- Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
- Patient has osteopenia of the spine (T-score of -1.0 or lower). A Bone Densiometry (DEXA) scan should be performed to rule out patients considered at risk for osteopenia.
- Patient has morbid obesity defined as a Body Mass Index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.
- Patient has a known allergy to silicone or barium sulfate.
- Patient 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.
- Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).
- Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
- Protrusion of the 20A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps.
- Patient has a violated endplate as determined by imaging balloons during fluoroscopy.
- Patient has a disc space that is too narrow for implantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PerQdisc PMCF1 Observational Trial to Evaluate the Clinical Performance and Safety of the PerQdisc Nucleus Replacement Device
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.
Read the detailed description
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.
- Conditions
- Degenerative Disc Disease, Chronic Low-back Pain
- Being tested
- PerQdisc
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerQdiscDrug
Also called PerQdisc Nucleus Replacement System
Observational trial to collect post-market safety and efficacy information in a limited number of human patients
| Study group | Role | What they receive |
|---|---|---|
| Chronic Discogenic Low Back Pain | 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. Receives: Drug: PerQdisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
PerQdisc Perfomance
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Measured: 6 months post implant
PerQdisc Perfomance
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Measured: 12 months post implant
PerQdisc Safety
Incidence of device expulsion and device fracture following surgery based on follow up X-rays and MRI's
Measured: 6 months post implant
PerQdisc Safety
Incidence of device expulsion and device fracture following surgery based on follow up x-rays and MRI's
Measured: 12 months post implant
Secondary outcomes (5)
Incidence of Secondary Surgeries
Incidence of revision surgery at the index level or other secondary lumbar surgery at a non-index level
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 6 months, 12 months, and 5 years following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start31 Dec 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Study withdrawn upon CE mark receipt
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Stabilization Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hess, MD, Study director, Spinal Stabilization TechnologiesJeff Golan, MD, Study director, Spinal Stabilization Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105490
- Sponsor's protocol ID
- PerQdisc PMCF1
- Acronym
- PMCF1
- Status last verified
- May 2025
- First submitted
- 11 Oct 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified outcome data will be available to participating investigators
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PerQdisc PMCF1 Observational Trial to Evaluate the Clinical Performance and Safety of the PerQdisc Nucleus Replacement Device
- ClinicalTrials.gov ID
- NCT05105490
- Acronym / sponsor ID
- PMCF1 / PerQdisc PMCF1
- Conditions
- Degenerative Disc Disease, Chronic Low-back Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn upon CE mark receipt
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spinal Stabilization TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Discogenic Low Back Pain | – | Drug: PerQdiscPatient 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Skeletally mature patients, age 21-60 years, with chronic low back pain of discogenic origin that is non-responsive to conservative, non-surgical therapy.
Key inclusion criteria (5 listed)
- 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.
- Patient has signed the approved Informed Consent Form.
Key exclusion criteria (20 listed)
- Patient has less than 6 mm of disc height.
- Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
- Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.
- Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
- Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerQdiscAlso: PerQdisc Nucleus Replacement SystemObservational trial to collect post-market safety and efficacy information in a limited number of human patients | Drug | Chronic Discogenic Low Back Pain |
Primary outcome
PerQdisc Perfomance
Time frame: 6 months post implant
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
PerQdisc Perfomance
Time frame: 12 months post implant
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
PerQdisc Safety
Time frame: 6 months post implant
Incidence of device expulsion and device fracture following surgery based on follow up X-rays and MRI's
PerQdisc Safety
Time frame: 12 months post implant
Incidence of device expulsion and device fracture following surgery based on follow up x-rays and MRI's
5 secondary outcomes
Incidence of Secondary Surgeries
Time frame: 6 months, 12 months, and 5 years following surgery
Maintenance of Disc Height
Time frame: 6 months, 12 months, and 5 years following surgery
Maintenance of Range of Motion
Time frame: 6 months, 12 months, and 5 years following surgery
Maintenance of Neurologic Status
Time frame: 6 months, 12 months, and 5 years following surgery
Use of Pain Medications
Time frame: 6 months, 12 months, and 5 years following surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. De-identified outcome data will be available to participating investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hess, MD study director
Spinal Stabilization Technologies
Jeff Golan, MD study director
Spinal Stabilization Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Chronic Low-back Pain, run by Spinal Stabilization Technologies at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PerQdisc Perfomance (time frame: 6 months post implant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.