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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degenerative Disc Disease | Device | lumbar interbody with posterior screw and rod instrumentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| radiographic evaluation | Standing anterior-posterior, lateral, flexion and extension images | Pre-Op to 2 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes | Visual Analog Scale, Oswestry Disability Index, Neurological Exam | pre-op to 2 years post-operative |
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Inclusion Criteria:
Exclusion Criteria:
• Presence of systemic or localized infection at the site of surgery
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Choll Kim, MD | Spine Institute of San Diego | Principal Investigator |
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Once data collection is complete and analyzed, we will submit to journals for publication
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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