Back to resultsStudy of an Expandable Interbody Device for the Lumbar Spine (CALIBER)
Primary Purpose
Degenerative Disc Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CALIBER
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
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
Sites / Locations
- South Florida Spine Institute at Mt Sinai Medical Center
- Carolina NeuroSurgery and Spine Associates
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CALIBER
Arm Description
1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion
Outcomes
Primary Outcome Measures
Fusion and Disc Height Maintenance
Inter-vertebral disc height in millimetres at 24 month follow up.
Fusion Assessment
An assessment of the fusion status of surgically treated spinal levels.
Secondary Outcome Measures
Patient Self Assessment
Oswestry Disability Index. A 10 item questionnaire with responses scored 0 to 5 and then presented as a percentage score from 0 to 100, with higher scores denoting more disability.
Visual Analog Scale for Back Pain
A visual scale from 0 to 100 in which the patient responds with their pain level by marking on the line, higher as more severe pain.
Full Information
NCT ID
NCT02075554
First Posted
February 4, 2014
Last Updated
February 2, 2021
Sponsor
Globus Medical Inc
Collaborators
Mt. Sinai Medical Center, Miami, Carolina Neurosurgery & Spine Associates
1. Study Identification
Unique Protocol Identification Number
NCT02075554
Brief Title
Study of an Expandable Interbody Device for the Lumbar Spine
Acronym
CALIBER
Official Title
Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Globus Medical Inc
Collaborators
Mt. Sinai Medical Center, Miami, Carolina Neurosurgery & Spine Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work status
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Lumbar interbody cages
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CALIBER
Arm Type
Other
Arm Description
1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion
Intervention Type
Device
Intervention Name(s)
CALIBER
Intervention Description
Expandable interbody spacer
Primary Outcome Measure Information:
Title
Fusion and Disc Height Maintenance
Description
Inter-vertebral disc height in millimetres at 24 month follow up.
Time Frame
24 months
Title
Fusion Assessment
Description
An assessment of the fusion status of surgically treated spinal levels.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patient Self Assessment
Description
Oswestry Disability Index. A 10 item questionnaire with responses scored 0 to 5 and then presented as a percentage score from 0 to 100, with higher scores denoting more disability.
Time Frame
Upto 24 mo
Title
Visual Analog Scale for Back Pain
Description
A visual scale from 0 to 100 in which the patient responds with their pain level by marking on the line, higher as more severe pain.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Cohen, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Florida Spine Institute at Mt Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Carolina NeuroSurgery and Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of an Expandable Interbody Device for the Lumbar Spine
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