OLIF25™ /OLIF51™ Study

NCT ID: NCT02657421

Last Updated: 2018-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Disc Disease Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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OLIF

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Spinal and Biologics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Advanced Neurosurgery Associates

Murrieta, California, United States

Site Status

University of California San Francisco (UCSF)

San Francisco, California, United States

Site Status

The B.A.C.K. Center

Melbourne, Florida, United States

Site Status

Foundation for Orthopaedic Research and Education (FORE)

Tampa, Florida, United States

Site Status

NewYork-Presbyterian/The Allen Hospital

New York, New York, United States

Site Status

Alleghany Health Network Research Institute

Pittsburgh, Pennsylvania, United States

Site Status

Ste Elisabeth hospital

Brussels, , Belgium

Site Status

FN Ostrava

Ostrava, Poruba, Czechia

Site Status

Clinique Du Mail

La Rochelle, , France

Site Status

Azienda Ospedaliera - Ospedale Civile di Legnano

Legnano, , Italy

Site Status

CUF Descobertas

Lisbon, , Portugal

Site Status

Orthospine Group

San Juan, , Puerto Rico

Site Status

Countries

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United States Belgium Czechia France Italy Portugal Puerto Rico

Other Identifiers

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P15-05

Identifier Type: -

Identifier Source: org_study_id

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