Lumbar Disc Disease Clinical Trial
— MOBIS_USOfficial title:
Prospective, Randomized, Data Registry Study of MOBIS II Structural Titanium (ST) Interbody Cage Compared to MOBIS Peek Cage for the Treatment of Spondylolisthesis and Degenerative Disc Disease
NCT number | NCT02852187 |
Other study ID # | 01MOBIS_US |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | November 2018 |
Verified date | March 2020 |
Source | Signus Medizintechnik GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Upstate Orthopedics | East Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
Signus Medizintechnik GmbH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fusion rates | Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans | 24 Months | |
Secondary | Subsidence | disc height demonstrated by radiographic evidence based on plain radiographs, and CT Scans | 24 Months | |
Secondary | Patient Reported Outcomes: Visual Analog Scale (VAS) | Comparison of pre-operative to post-operative evaluations | Through 24 Months | |
Secondary | Patient Reported Outcomes: Oswestry Disability Index | Comparison of pre-operative to post-operative evaluations | Through 24 Months | |
Secondary | Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L | Comparison of pre-operative to post-operative evaluations | Through 24 Months |
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