M51.3
Conditions
Interventions
Group 1: The PerQdisc device is intended to replace the nucleus pulposus in skeletally mature patients at least 18 years of age with symptomatic single level degenerative disc disease (DDD) at levels
Sponsors
Spinal Stabilization Technologies, LTD
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for subject selection Prospective subjects must meet all of the inclusion criteria as listed below to participate in this clinical study. 1. Patient is skeletally mature and between 18 and 60 years of age. 2. Patient has degenerative disc disease (DDD) at a single level between L1 and S1 confirmed by: a. History and clinical findings suggestive of symptomatic DDD,b. Darkened disc on MRI in T2 weighted images, and c. Decreased disc height (decreased greater than 2 mm compared to adjacent cranial or caudal disc height) with minimum disc height of 6 mm). 3. Patient has pre-operative back pain VAS score of greater than or equal to 4 (0-10 scale). 4. Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale). 5. Patient has received conservative (non-surgical) treatment for back pain for a minimum of 6 months. 6. Patient agrees to comply with long-term follow-up visit schedule and completing study questionnaires and Patient has signed the approved Informed Consent Form.
Exclusion criteria
Exclusion criteria: Exclusion criteria for patient selection Patient must not meet any of the exclusion criteria included in the list that follows. 1. Patient has had prior lumbar spine surgery. 2. Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs. 3. Patient has more than one-third (1/3) of posterior annulus (defined by the medial margin of the pedicles) bulging at level to be treated. 4. Patient has ankylosing spondylitis or other spondyloarthropathy. 5. Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2mm. 6. Patient has congenital stenosis or epidural lipomatosis. 7. Patient has significant facet disease. 8. Patient has any known active malignancy. 9. Patient has previously undergone immunosuppressive therapy. 10. Patient has active local or systemic infection. 11. Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease, including AIDS, ARC, HIV. 12. Patient has diabetes mellitus (Type 1 or 2), requiring daily insulin management. 13. Patient has osteopenia of the spine (T-score less than -1.0) All females 45 years of age or older and all males 50 years or older should have a DEXA scan to confirm this exclusion. 14. Patient has morbid obesity defined as body mass index (BMI) more than 40 or a weight more than 45 kg (100 lbs) over ideal body weight. 15. Patient is pregnant or plans to become pregnant during the course of the study. 16. Patient has a known allergy to silicone (the polymer and balloon material) or barium sulfate (in the polymer). 17. Patient participated in another investigational drug or device study within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: • Improvement at 6 months in degree of disability as measured by Oswestry Disability Index (ODI) • Improvement at 6 months in back pain as measured by 10-centimeter Visual Analog Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: • Individual components of the ODI • Leg pain as measured by 10-centimeter Visual Analog Scale (VAS) (Patients without leg pain at baseline will be excluded from this analysis) • Disc height • Range of motion on flexion/extension radiographs • Incidence of maintenance or improvement in neurological status • Incidence of serious adverse events that are related to the procedure or device • Incidence of late revision surgeries or crossover to established procedures or techniques • Incidence of device extrusions or migrations • Incidence of device placement success • Current pain and analgesic medications (dose and frequency) • Return to work Technical success is determined as follows: • Good position of the device is demonstrated on the intra-operative radiographs. Device migration will be determined as follows: • A device that is expulsed from the disc space. • A device that partially protrudes through the outer margin of the annulus. | — |
Countries
Germany, Switzerland
Contacts
Public ContactMichael Hess
Wirbelsaeulen Institut Munich WIM
Outcome results
None listed