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

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: Degenerative Disc Disease

• Registration Number: NCT02388022
• Lead Sponsor: Globus Medical Inc

Brief Summary

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

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Status Verified: 2015-03
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-13
• Study Completion: 2016-03
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
degenerative disc disease	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.

Primary Outcome Measures

Name	Time	Method
radiographic evaluation	Pre-Op to 2 years post-operative	Standing anterior-posterior, lateral, flexion and extension images

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes	pre-op to 2 years post-operative	Visual Analog Scale, Oswestry Disability Index, Neurological Exam