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Business Decision
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The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oblique Lateral Interbody Fusion | Procedure | The oblique lateral interbody fusion (OLIF) procedures at L2-L5 (OLIF25™) and L5-S1 (OLIF51™) is a minimally invasive surgical option for degenerative lumbar disease. This approach allows for psoas-preserving access to the lumbar spine and minimizes the need to reposition the patient during surgery for accessing additional spinal levels for the interbody fusion portion of the procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Back and Leg Pain Measured by Visual Analogue Scales (VAS) | 24 months | |
| Oswestry Disability Index (ODI) | 24 months | |
| European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire | 24 months | |
| Neurological deficits assessed by neurological status | Neurological status is based on seven components of measurements: Motor function; Sensory function; Deep Tendon reflexes; Sympathetic Exam; Claudication; Urinary bladder retention/Bowel retention; and Sexual Dysfunction. | 24 months |
| Rate of adverse events | 24 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Surgical Data | Surgical data include mean blood loss, operative time, and length of hospital stay (LOS). | Day 0 to Day 5 |
| Work status | 24 months |
Inclusion Criteria:
Exclusion Criteria:
1. Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).
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Patients who have surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Neurosurgery Associates | Murrieta | California | 92563 | United States | ||
| University of California San Francisco (UCSF) |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013121 | Spinal Curvatures |
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| Spino-Pelvic Measurements by X-ray | 24 months |
| San Francisco |
| California |
| 94143 |
| United States |
| The B.A.C.K. Center | Melbourne | Florida | 32901 | United States |
| Foundation for Orthopaedic Research and Education (FORE) | Tampa | Florida | 33637 | United States |
| NewYork-Presbyterian/The Allen Hospital | New York | New York | 10034 | United States |
| Alleghany Health Network Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| Ste Elisabeth hospital | Brussels | Belgium |
| FN Ostrava | Ostrava | Poruba | Czechia |
| Clinique Du Mail | La Rochelle | 17000 | France |
| Azienda Ospedaliera - Ospedale Civile di Legnano | Legnano | 20025 | Italy |
| CUF Descobertas | Lisbon | 1998-018 | Portugal |
| Orthospine Group | San Juan | 00910-3428 | Puerto Rico |