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
Back and Leg Pain Measured by Visual Analogue Scales (VAS)	24 months
Oswestry Disability Index (ODI)	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.
Rate of adverse events	24 months

Trial Locations

Locations (12)

Orthospine Group; 🇵🇷 San Juan, Puerto Rico

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

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

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

Clinique Du Mail; 🇫🇷 La Rochelle, France

FN Ostrava; 🇨🇿 Ostrava, Poruba, Czechia

Ste Elisabeth hospital; 🇧🇪 Brussels, Belgium

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

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

CUF Descobertas; 🇵🇹 Lisbon, Portugal

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

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