A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 168
- Locations
- 12
- Primary Endpoint
- Back and Leg Pain Measured by Visual Analogue Scales (VAS)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is 18 years of age or older.
- •Patient agrees to participate in the study and is able to sign the informed consent/data release form.
- •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
- •Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).
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
Time Frame: 24 months
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.
Rate of adverse events
Time Frame: 24 months