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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02388022

Enrollment

200

Registered

2015-03-13

Start date

2014-01-31

Completion date

2016-03-31

Last updated

2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease

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.

Interventions

DEVICEDegenerative Disc Disease

lumbar interbody with posterior screw and rod instrumentation

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026