Study of an Expandable Interbody Device for the Lumbar Spine
CALIBER
Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach
1 other identifier
interventional
58
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
February 3, 2021
CompletedFebruary 3, 2021
February 1, 2021
4.3 years
February 4, 2014
August 25, 2020
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Fusion and Disc Height Maintenance
Inter-vertebral disc height in millimetres at 24 month follow up.
24 months
Fusion Assessment
An assessment of the fusion status of surgically treated spinal levels.
24 months
Secondary Outcomes (2)
Patient Self Assessment
Upto 24 mo
Visual Analog Scale for Back Pain
24 months
Study Arms (1)
CALIBER
OTHER1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Globus Medical Inclead
- Mt. Sinai Medical Center, Miamicollaborator
- Carolina Neurosurgery & Spine Associatescollaborator
Study Sites (2)
South Florida Spine Institute at Mt Sinai Medical Center
Miami Beach, Florida, 33140, United States
Carolina NeuroSurgery and Spine Associates
Charlotte, North Carolina, 28204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brandon Bucklen
- Organization
- Globus Medical Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Cohen, MD
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2014
First Posted
March 3, 2014
Study Start
July 1, 2012
Primary Completion
November 1, 2016
Study Completion
February 1, 2017
Last Updated
February 3, 2021
Results First Posted
February 3, 2021
Record last verified: 2021-02