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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388022
• Other study ID #: RGC13-005-PL_A
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: August 9, 2016
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Globus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• Degenerative Disc Disease
lumbar interbody with posterior screw and rod instrumentation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Globus Medical Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic evaluation	Standing anterior-posterior, lateral, flexion and extension images	Pre-Op to 2 years post-operative	No
Secondary	Clinical outcomes	Visual Analog Scale, Oswestry Disability Index, Neurological Exam	pre-op to 2 years post-operative	No