A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.

August 9, 2016 updated by: Globus Medical Inc
The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi center retrospective study with 200 patients. Sites will screen their patient records for patients who have had a TLIF utilizing the CALIBER® expandable interbody spacer in conjunction with the REVOLVE® or REVERE® posterior stabilization systems and subsequent follow-up visits.

The study aims to collect both pre-operative and post-operative data at the 6, 12 and 24 month time points according to existing standard of care and the surgeon's custom and practice.

Study Type

Observational

Enrollment (Actual)

200

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Both male and female between the ages of 18 and 80 with objective evidence of degenerative disc disease between L2 and S1 at 1-2 contiguous levels.

Description

Inclusion Criteria:

  • Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 resulting from degeneration of disc confirmed by history and radiographic studies.
  • At least 18 years of age and maximum 80 years of age

Exclusion Criteria:

  • • Presence of systemic or localized infection at the site of surgery

    • More than 2 levels to be instrumented
    • Previous fusion attempt at the involved level(s)
    • Spondylolisthesis unable to be reduced to Grade 1
    • Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
    • Diagnosis of a condition or on postoperative medication(s), which may interfere with bony/soft tissue healing
    • Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
    • History of substance abuse (drugs or alcohol)
    • Mentally incompetent or prisoner

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
degenerative disc disease
Patients who have had a transforaminal lumbar interbody fusion at 1-2 contiguous levels with the CALIBER® expandable spacer and have completed at least 2 year follow-up.
Device: Degenerative Disc Disease
lumbar interbody with posterior screw and rod instrumentation
Other Names:
  • CALIBER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic evaluation
Time Frame: Pre-Op to 2 years post-operative
Standing anterior-posterior, lateral, flexion and extension images
Pre-Op to 2 years post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: pre-op to 2 years post-operative
Visual Analog Scale, Oswestry Disability Index, Neurological Exam
pre-op to 2 years post-operative

Collaborators and Investigators

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

Sponsor

Globus Medical Inc

Investigators

  • Principal Investigator: Choll Kim, MD, Spine Institute of San Diego

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

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGC13-005-PL_A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once data collection is complete and analyzed, we will submit to journals for publication

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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