OLIF25™ /OLIF51™ Study

Terminated

• Conditions: Degenerative Disc Disease; Scoliosis

• Registration Number: NCT02657421
• Lead Sponsor: Medtronic Spinal and Biologics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Status Verified: 2017-07
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-03
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	24 months
Rate of adverse events	24 months
Back and Leg Pain Measured by Visual Analogue Scales (VAS)	24 months
European Quality of Life-5 Dimensions (EQ-5D) self-report questionnaire	24 months
Neurological deficits assessed by neurological status	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.

Trial Locations

Locations (12)

Advanced Neurosurgery Associates; 🇺🇸 Murrieta, California, United States

University of California San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

The B.A.C.K. Center; 🇺🇸 Melbourne, Florida, United States

Foundation for Orthopaedic Research and Education (FORE); 🇺🇸 Tampa, Florida, United States

NewYork-Presbyterian/The Allen Hospital; 🇺🇸 New York, New York, United States

Alleghany Health Network Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Ste Elisabeth hospital; 🇧🇪 Brussels, Belgium

FN Ostrava; 🇨🇿 Ostrava, Poruba, Czechia

Clinique Du Mail; 🇫🇷 La Rochelle, France

Azienda Ospedaliera - Ospedale Civile di Legnano; 🇮🇹 Legnano, Italy

Scroll for more (2 remaining)