OLIF25™ /OLIF51™ Study

May 31, 2018 updated by: Medtronic Spinal and Biologics

A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: 24 months
24 months
Rate of adverse events
Time Frame: 24 months
24 months
Back and Leg Pain Measured by Visual Analogue Scales (VAS)
Time Frame: 24 months
24 months
European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire
Time Frame: 24 months
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.
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Data
Time Frame: Day 0 to Day 5
Surgical data include mean blood loss, operative time, and length of hospital stay (LOS).
Day 0 to Day 5
Work status
Time Frame: 24 months
24 months
Spino-Pelvic Measurements by X-ray
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Spinal and Biologics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

May 3, 2018

Study Completion (Actual)

May 3, 2018

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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