Study of an Expandable Interbody Device for the Lumbar Spine (CALIBER)

February 2, 2021 updated by: Globus Medical Inc

Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • South Florida Spine Institute at Mt Sinai Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolina Neurosurgery and Spine Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CALIBER
1 or 2 levels of DDD between L2 and S1, treated with transforaminal interbody fusion
Device: CALIBER
Expandable interbody spacer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion and Disc Height Maintenance
Time Frame: 24 months
Inter-vertebral disc height in millimetres at 24 month follow up.
24 months
Fusion Assessment
Time Frame: 24 months
An assessment of the fusion status of surgically treated spinal levels.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Self Assessment
Time Frame: Upto 24 mo
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.
Upto 24 mo
Visual Analog Scale for Back Pain
Time Frame: 24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Globus Medical Inc

Collaborators

Mt. Sinai Medical Center, Miami
Carolina Neurosurgery & Spine Associates

Investigators

  • Principal Investigator: Dan Cohen, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGC10-009-001-PL_H_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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