Degenerative Disc Disease, Lumbar Disc Herniation, Spondylolisthesis
Conditions
Keywords
Degenerative Disk Disease, Lumbar Fusion, Minimally Invasive Surgery, Lumbar Disk Disease
Brief summary
This study is undertaken to evaluate the outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF). Specifically, the study seeks to measure outcomes on radiological imaging, outcomes reported by the patients on standardized questionnaires, and complication rates.
Interventions
PROCEDUREOblique Lateral Lumbar Fusion
Oblique lateral lumbar interbody fusion (OLLIF) is a lumbar spinal fusion. OLLIF is performed with the patient in the prone position and employs an oblique lateral approach that enables the instrumentation to pass through Kambin's triangle which is defined as the space between the exiting nerve, the superior border of the caudal vertebra, and the superior articulating process of the inferior facet. This approach may be performed without direct visualization, guided by electrophysiological monitoring and biplanar fluoroscopy. During the approach, a blunt probe is used to make contact with the disc, followed by a series of gentle dilations. Discectomy is performed through a 10-mm access portal. The cage is inserted under continued electrophysiological monitoring and fluoroscopy.
Sponsors
Tristate Brain and Spine Institute
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis, confirmed by imaging, of one of the following conditions: severe degenerative disc disease, spondylolisthesis, spinal stenosis, disc herniation * Completion of a full course of conservative therapy. Conservative therapy may include physical therapy, therapeutic injections, bracing and behavioral modification.
Exclusion criteria
* bony obstruction of the approach * significant spinal canal stenosis * large facet hypertrophy * grade II listhesis * scoliosis with Cobb angle \> 10º * Patients who underwent procedures that were converted to open fusions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported disability on the Oswestry Disability Index | One year after surgery | The Oswestry Disability Index is a commonly used tool to assess disability due to low back pain. The Oswestry is assessed on a standardized questionnaire and the scale ranges from 0% to 100% disability. A lower score is considered less disability. |
| Fusion rate | One year after surgery | The rate of bony fusion as determined by independent radiologists on post-operative CT scans. Radiologists will determine whether each level that was operated on was fused, or not fused. |
| Rate of Neuropraxia | One year after surgery | Neuropraxia is defined as lower extremity weakness of 3/5 or below on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery. |
| Rate of Nerve Root Irritation | One year after surgery | Nerve Root Irritation is defined as lower extremity paresthesias or dysesthesias corresponding to dermatome of the level of surgery or weakness of 4/5 or above on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy Time | During surgery. | The time fluoroscopy was used during surgery measured in seconds. |
| Rate of screw fracture | One year after surgery | The percentage of all screws placed in the study group that is determined to have fractured on postoperative imaging. Imaging is read by independent radiologists. |
| Infection Rate | Immediately after surgery | The percentage of patients that experienced a postoperative surgical site infection. |
| Patient reported pain on a 10-point pain scale | One year after surgery | The level of pain reported by the patient on a standard 10-point pain scale. The scale goes from 0 (no pain) to 10 (worst pain imaginable) |
| Bleeding Rate | During surgery and immediately after surgery | The percentage of patients that experienced bleeding during surgery or immediately after surgery that required transfusion. |
| Surgery Time | During surgery | Skin to skin surgery time measured in minutes |
| Hospital stay | Immediately after surgery | The number of nights spent in the hospital following the surgery measured in days |
| Blood Loss | During surgery | The amount of blood lost during the surgery measured in milliliters. |
Countries
United States
Outcome results
None listed