Clinical Trials Directory

Trials / Terminated

TerminatedNCT02657421

OLIF25™ /OLIF51™ Study

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

Status
Terminated
Phase
Study type
Observational
Enrollment
168 (actual)
Sponsor
Medtronic Spinal and Biologics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREOblique Lateral Interbody FusionThe 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

Timeline

Start date
2015-11-01
Primary completion
2018-05-03
Completion
2018-05-03
First posted
2016-01-15
Last updated
2018-06-04

Locations

12 sites across 7 countries: United States, Belgium, Czechia, France, Italy, Portugal, Puerto Rico

Source: ClinicalTrials.gov record NCT02657421. Inclusion in this directory is not an endorsement.