OLIF25™ /OLIF51™ Study

Description

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 Start Date

November 2015

Estimated Completion Date

November 2020

Interventions

  • Procedure: Oblique Lateral Interbody Fusion

Specialties

  • Neurology: Demyelinating Disorders,Spine
  • Family Medicine: Orthopedic/Physical Med
  • Orthopedics: Spine,Surgical Technique

MeSH Terms

  • Bone Diseases
  • Intervertebral Disc Degeneration
  • Musculoskeletal Diseases
  • Spinal Diseases

Study ID

Medtronic Spinal and Biologics -- P15-05

Status

Recruiting

Trial ID

NCT02657421

Study Type

Observational [Patient Registry]

Trial Phase

N/A

Enrollment Quota

500

Sponsor

Medtronic Spinal and Biologics

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
NewYorkPresbyterianThe Allen Hospital - New York, New York 44.9 miles Zachary Messer 212-932-4410 None
Alleghany Health Network Research Institute - Pittsburgh, Pennsylvania 358.2 miles Matt Yeager 412-359-4272 None
Heartland Neurosurgery - Waterloo, Iowa 986.3 miles Anne Pittman 319-226-9888 None
The BACK Center - Melbourne, Florida 1,001.9 miles Kim Sellati 321-541-1587 None
Foundation for Orthopaedic Research and Education FORE - Tampa, Florida 1,049.5 miles Debbi Warren 813-978-9700 None
Foundation for Orthopaedic Research and Education FORE - Tampa, Florida 1,049.5 miles Debbi Warren 813-978-9700 None
Advanced Neurosurgery Associates - Murrieta, California 2,447.7 miles Ahtziri Fonseca 707-694-2372 None
University of California San Francisco UCSF - San Francisco, California 2,606.4 miles Erika Cavallone 415-353-2240 None
University of California San Francisco UCSF - San Francisco, California 2,606.4 miles Erika Cavallone 415-353-2240 None

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