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OpenTrials
Completed

NCT Number: NCT02388022

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

The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Degenerative Disc Disease

Device

lumbar interbody with posterior screw and rod instrumentation

Other names: CALIBER

Primary outcomes

  1. radiographic evaluation

    Time frame: Pre-Op to 2 years post-operative

    Standing anterior-posterior, lateral, flexion and extension images

Secondary outcomes

  1. Clinical outcomes

    Time frame: pre-op to 2 years post-operative

    Visual Analog Scale, Oswestry Disability Index, Neurological Exam

Sponsors and collaborators

Lead sponsor

Globus Medical Inc

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 13, 2015
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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