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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Degenerative Disc Disease

Intervention Type DEVICE

lumbar interbody with posterior screw and rod instrumentation

Interventions

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Degenerative Disc Disease

lumbar interbody with posterior screw and rod instrumentation

Intervention Type DEVICE

Other Intervention Names

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CALIBER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No