Status:
COMPLETED
INDEPENDENCE Spacer for Lumbar Fusion
Lead Sponsor:
Globus Medical Inc
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-65 years
Brief Summary
The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENC...
Detailed Description
A total of thirty subjects will be enrolled at Scott \& White Healthcare. The INDEPENDENCE spacer will be filled with autogenous bone graft material. The devices subject to this Agreement have receive...
Eligibility Criteria
Inclusion
- • Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 with degeneration confirmed by patient history and radiographic examination
- Experience pain, functional deficit and/or neurological deficit for a minimum of six months
- Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months and/or presentation with progressive symptoms of nerve root or spinal cord compression prior to enrollment
- At least 18 years of age and maximum 65 years of age
- Ability to provide Informed Consent for study participation and to return for all follow-up visits
Exclusion
- • Presence of systemic or localized infection at the site of surgery
- More than 2 levels to be instrumented
- Previous fusion attempt at the involved level(s)
- More than three previous open, posterior, lumbar spinal surgical procedures at the involved level(s)
- Trauma at the level(s) to be fused
- More than grade 1 spondylolisthesis
- Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
- Immunosuppressive disorder
- Pregnant or interested in becoming pregnant during the duration of the study
- History of substance abuse (drugs or alcohol)
- Any known allergy to a metal alloy
- Mentally incompetent or prisoner
- Currently a participant in another study
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02299323
Start Date
January 1 2012
End Date
August 1 2016
Last Update
August 10 2016
Active Locations (1)
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1
Scott & White Healthcare
Temple, Texas, United States, 76508