Clinical trial NCT02657421: OLIF25™ /OLIF51™ Study
Official title: A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Disc Disease
Scoliosis
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have surgery from L2-L5 for OLIF25™ and/or from L5-S1 for OLIF51™ for degenerative disc disease or degenerative scoliosis.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Back and Leg Pain Measured by Visual Analogue Scales (VAS)
timeFrame: 24 months
measure: Oswestry Disability Index (ODI)
timeFrame: 24 months
measure: European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire
timeFrame: 24 months
measure: Neurological deficits assessed by neurological status
timeFrame: 24 months
measure: Rate of adverse events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: Surgical Data
timeFrame: Day 0 to Day 5
measure: Work status
timeFrame: 24 months
measure: Spino-Pelvic Measurements by X-ray
timeFrame: 24 months
Locations:
city: Murrieta
country: United States
facility: Advanced Neurosurgery Associates
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF)
state: California
city: Melbourne
country: United States
facility: The B.A.C.K. Center
state: Florida
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education (FORE)
state: Florida
city: New York
country: United States
facility: NewYork-Presbyterian/The Allen Hospital
state: New York
city: Pittsburgh
country: United States
facility: Alleghany Health Network Research Institute
state: Pennsylvania
city: Brussels
country: Belgium
facility: Ste Elisabeth hospital
city: Ostrava
country: Czechia
facility: FN Ostrava
state: Poruba
city: La Rochelle
country: France
facility: Clinique Du Mail
city: Legnano
country: Italy
facility: Azienda Ospedaliera - Ospedale Civile di Legnano
city: Lisbon
country: Portugal
facility: CUF Descobertas
city: San Juan
country: Puerto Rico
facility: Orthospine Group
Study officials:
References: