Clinical trial NCT05105490: Post Market Observational Trial for the PerQdisc Nucleus Replacement Device
Official title: PerQdisc PMCF1 Observational Trial to Evaluate the Clinical Performance and Safety of the PerQdisc Nucleus Replacement Device
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Degenerative Disc Disease
Chronic Low-back Pain
Lead sponsor: Spinal Stabilization Technologies
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
measure: PerQdisc Perfomance
timeFrame: 6 months post implant
measure: PerQdisc Perfomance
timeFrame: 12 months post implant
measure: PerQdisc Safety
timeFrame: 6 months post implant
measure: PerQdisc Safety
timeFrame: 12 months post implant
Secondary outcomes:
measure: Incidence of Secondary Surgeries
timeFrame: 6 months, 12 months, and 5 years following surgery
measure: Maintenance of Disc Height
timeFrame: 6 months, 12 months, and 5 years following surgery
measure: Maintenance of Range of Motion
timeFrame: 6 months, 12 months, and 5 years following surgery
measure: Maintenance of Neurologic Status
timeFrame: 6 months, 12 months, and 5 years following surgery
measure: Use of Pain Medications
timeFrame: 6 months, 12 months, and 5 years following surgery
Other outcomes:
Locations:
city: Deggendorf
country: Germany
facility: Donauisar Klinikum Deggendorf
Study officials:
affiliation: Spinal Stabilization Technologies
name: Michael Hess, MD
role: STUDY_DIRECTOR
affiliation: Spinal Stabilization Technologies
name: Jeff Golan, MD
role: STUDY_DIRECTOR
References: