N/A
N=58
Study of an Expandable Interbody Device for the Lumbar Spine
Degenerative Disc Disease
Bottom Line
View on ClinicalTrials.gov: NCT02075554 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Fusion and Disc Height Maintenance — 11.60 millimetres
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CALIBER (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Globus Medical Inc
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fusion and Disc Height Maintenance |
11.60 | — |
| PRIMARY Fusion Assessment |
33 | — |
| SECONDARY Patient Self Assessment |
18.79 | — |
| SECONDARY Visual Analog Scale for Back Pain |
10.71 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02075554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.