INDEPENDENCE Spacer for Lumbar Fusion

Completed

Conditions studied: Degenerative Disc Disease

In brief

The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.

Key facts

Study ID

NCT02299323

Run by

Globus Medical Inc

People needed

30

Starts

2012-01-01

Expected to finish

2016-08-01

Last updated by the study team

2016-08-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

• Scott & White Healthcare — Temple, Texas, United States

Full record on ClinicalTrials.gov

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