Study of an Expandable Interbody Device for the Lumbar Spine

Completed · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from patients in this 2 year follow-up clinical study.

Key facts

Study ID

NCT02075554

Run by

Globus Medical Inc

People needed

58

Starts

2012-07-01

Expected to finish

2017-02-01

Last updated by the study team

2021-02-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DDD at 1 or 2 levels between L2 and S1
• Between 18 and 80 years of age
• Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months
• Ability to provide a signed Informed Consent

You may not qualify if…

• Trauma at level(s) to be fused
• Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
• Immunosuppressive disorder
• History of substance abuse
• Any known allergy to a metal alloy

Where it is running

• South Florida Spine Institute at Mt Sinai Medical Center — Miami Beach, Florida, United States
• Carolina NeuroSurgery and Spine Associates — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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