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Study of an Expandable Interbody Device for the Lumbar Spine

NCT02075554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-02-03

Study results available
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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.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

CALIBER

Expandable interbody spacer

Sponsors & Collaborators

  • Mt. Sinai Medical Center, Miami

    collaborator OTHER

  • Carolina Neurosurgery & Spine Associates

    collaborator OTHER

  • Globus Medical Inc

    lead INDUSTRY

Principal Investigators

  • Dan Cohen, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-11-30
Completion
2017-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075554 on ClinicalTrials.gov