CompletedNot Applicable

Study of an Expandable Interbody Device for the Lumbar Spine

United States58 participantsStarted 2012-07

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Fusion and Disc Height Maintenance

Timeframe: 24 months

Fusion Assessment

Timeframe: 24 months

Trial details

NCT IDNCT02075554

SponsorGlobus Medical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11

Results submitted2020-08-25

View on ClinicalTrials.gov More Degenerative Disc Disease trials