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

NCT02388022 | Completed

• 1 other identifier: RGC13-005-PL_A
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• radiographic evaluation

  Standing anterior-posterior, lateral, flexion and extension images

  Pre-Op to 2 years post-operative

Secondary Outcomes (1)

• Clinical outcomes

  pre-op to 2 years post-operative

Study Arms (1)

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.

Device: Degenerative Disc Disease

Interventions

Degenerative Disc Disease DEVICE

lumbar interbody with posterior screw and rod instrumentation

Also known as: CALIBER

degenerative disc disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both male and female between the ages of 18 and 80 with objective evidence of degenerative disc disease between L2 and S1 at 1-2 contiguous levels.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Globus Medical Inc: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Choll Kim, MD

  Spine Institute of San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will share