Lumbar Disc Disease
Conditions
Keywords
Intervertebral Disc Degeneration, Lumbar Spinal Disease
Brief summary
Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1
Detailed description
The protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patient should have completed at least six (6) months of non-operative treatment. Patients may have had a previous non-fusion surgery at the involved spinal level(s) and will be followed clinically up to two years.
Interventions
DEVICESIGNUS MOBIS PEEK Cage
Lumbar Interbody Fusion
DEVICESIGNUS MOBIS II ST Cage
Lumbar Interbody Fusion
Sponsors
Signus Medizintechnik GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. The patient has symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. 2. The patient has documented conservative (non-operative) treatment for at least 6 months. 3. The patient has a VAS back pain of ≥ 60 mm. 4. The patient has an ODI ≥ 40%. 5. The patient is at least 18 years of age and skeletally mature. 6. The general condition of the patient is appropriate for surgery, as evaluated by the Investigator. 7. The patient is willing and able to comply with study requirements. 8. The patient has agreed to participate in the study.
Exclusion criteria
1. The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s). 2. The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age. 3. The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s). 4. The patient has diffuse multilevel neoplastic disease such that no adjacent normal segments exist for engagement or instrumentation. 5. The patient has an active infection. 6. The patient is pregnant or is planning on becoming pregnant in the next two years. 7. The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues. 8. The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum/titanium. 9. The patient is currently enrolled in an investigational spine study. 10. The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease. 11. The patient has symptomatic fibrous arachnoiditis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion rates | 24 Months | Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subsidence | 24 Months | disc height demonstrated by radiographic evidence based on plain radiographs, and CT Scans |
| Patient Reported Outcomes: Visual Analog Scale (VAS) | Through 24 Months | Comparison of pre-operative to post-operative evaluations |
| Patient Reported Outcomes: Oswestry Disability Index | Through 24 Months | Comparison of pre-operative to post-operative evaluations |
| Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L | Through 24 Months | Comparison of pre-operative to post-operative evaluations |
Countries
United States
Outcome results
None listed