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OLIF25™ /OLIF51™ Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657421
Recruitment Status : Terminated (Business Decision)
First Posted : January 15, 2016
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Study Description
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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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Scoliosis Procedure: Oblique Lateral Interbody Fusion

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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 Start Date : November 2015
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Groups and Cohorts
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Intervention Details:
  • Procedure: Oblique Lateral Interbody Fusion
    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
    Other Name: OLIF

Outcome Measures
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Primary Outcome Measures :
  1. Back and Leg Pain Measured by Visual Analogue Scales (VAS) [ Time Frame: 24 months ]
  2. Oswestry Disability Index (ODI) [ Time Frame: 24 months ]
  3. European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire [ Time Frame: 24 months ]
  4. 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.

  5. Rate of adverse events [ Time Frame: 24 months ]

Other Outcome Measures:
  1. Surgical Data [ Time Frame: Day 0 to Day 5 ]
    Surgical data include mean blood loss, operative time, and length of hospital stay (LOS).

  2. Work status [ Time Frame: 24 months ]
  3. Spino-Pelvic Measurements by X-ray [ Time Frame: 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657421


Locations
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United States, California
Advanced Neurosurgery Associates
Murrieta, California, United States, 92563
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
United States, Florida
The B.A.C.K. Center
Melbourne, Florida, United States, 32901
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, United States, 33637
United States, New York
NewYork-Presbyterian/The Allen Hospital
New York, New York, United States, 10034
United States, Pennsylvania
Alleghany Health Network Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Belgium
Ste Elisabeth hospital
Brussels, Belgium
Czechia
FN Ostrava
Ostrava, Poruba, Czechia
France
Clinique Du Mail
La Rochelle, France, 17000
Italy
Azienda Ospedaliera - Ospedale Civile di Legnano
Legnano, Italy, 20025
Portugal
CUF Descobertas
Lisbon, Portugal, 1998-018
Puerto Rico
Orthospine Group
San Juan, Puerto Rico, 00910-3428
Sponsors and Collaborators
Medtronic Spinal and Biologics
More Information
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Additional Information:

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Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT02657421    
Other Study ID Numbers: P15-05
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: July 2017
Additional relevant MeSH terms:
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Scoliosis
Intervertebral Disc Degeneration
Spinal Curvatures
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases