OLIF25™ /OLIF51™ Study

Medtronic Spinal and Biologics168 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

168

Conditions

Degenerative Disc Disease Scoliosis

Interventions

Oblique Lateral Interbody FusionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is 18 years of age or older. 2. Patient agrees to participate in the study and is able to sign the informed consent/data release form. 3. Patient is undergoing surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis. Exclusion Criteria: 1\. Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).

Locations (12)

Advanced Neurosurgery Associates

Murrieta, California, United States

University of California San Francisco (UCSF)

San Francisco, California, United States

The B.A.C.K. Center

Melbourne, Florida, United States

Outcomes

Primary Outcomes

Back and Leg Pain Measured by Visual Analogue Scales (VAS)

Time frame: 24 months

Oswestry Disability Index (ODI)

Time frame: 24 months

European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire

Time frame: 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.

Time frame: 24 months

Rate of adverse events

Time frame: 24 months

Data from ClinicalTrials.gov

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