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

Globus Medical

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Device: Degenerative Disc Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02388022

RGC13-005-PL_A

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

200 participants in 1 patient group

degenerative disc disease

Description:

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.

Treatment:

Device: Degenerative Disc Disease