Post Market Observational Trial for the PerQdisc Nucleus Replacement Device (PMCF1)

• ClinicalTrials.gov Identifier: NCT05105490
• Recruitment Status: Not yet recruiting
• First Posted: November 3, 2021
• Last Update Posted: November 26, 2021
• Sponsor: Spinal Stabilization Technologies
• Information provided by (Responsible Party): Spinal Stabilization Technologies

Study Description

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.

Condition or disease	Intervention/treatment
Degenerative Disc Disease; Chronic Low-back Pain	Drug: PerQdisc

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

• Study Type: Observational
• Estimated Enrollment: 72 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PerQdisc PMCF1 Observational Trial to Evaluate the Clinical Performance and Safety of the PerQdisc Nucleus Replacement Device
• Estimated Study Start Date: December 31, 2021
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: October 31, 2027

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Drug: PerQdisc; Observational trial to collect post-market safety and efficacy information in a limited number of human patients; Other Name: PerQdisc Nucleus Replacement System

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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

Secondary Outcome Measures :

1. Incidence of Secondary Surgeries [ Time Frame: 6 months, 12 months, and 5 years following surgery ]
   Incidence of revision surgery at the index level or other secondary lumbar surgery at a non-index level
2. Maintenance of Disc Height [ Time Frame: 6 months, 12 months, and 5 years following surgery ]
   Intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline
3. Maintenance of Range of Motion [ Time Frame: 6 months, 12 months, and 5 years following surgery ]
   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.
4. Maintenance of Neurologic Status [ Time Frame: 6 months, 12 months, and 5 years following surgery ]
   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.
5. Use of Pain Medications [ Time Frame: 6 months, 12 months, and 5 years following surgery ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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.

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.

Contacts and Locations

Contacts

Contact: JEFFREY GRIEBEL; +13032468241; jlgriebel@sstspine.com

Locations

Germany

Donauisar Klinikum Deggendorf

Deggendorf, Germany, 94469

Sponsors and Collaborators

Spinal Stabilization Technologies

Investigators

• Study Director: Michael Hess, MD; Spinal Stabilization Technologies
• Study Director: Jeff Golan, MD; Spinal Stabilization Technologies

More Information

• Responsible Party: Spinal Stabilization Technologies
• ClinicalTrials.gov Identifier: NCT05105490
• Other Study ID Numbers: PerQdisc PMCF1
• First Posted: November 3, 2021
• Last Update Posted: November 26, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified outcome data will be available to participating investigators
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Intervertebral Disc Degeneration; Low Back Pain; Back Pain; Pain; Neurologic Manifestations; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases