Trials / Terminated

TerminatedNCT02068729

Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine

A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®

Status: Terminated
Phase: —
Study type: Observational
Enrollment: 131 (actual)

Sponsor: K2M, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed description

An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Safety will be assessed by the following: 1.) Evaluation of all adverse events including device related, procedure related and additional serious adverse events; 2.) Additional surgical intervention at the operative site including the need for removals, revisions, re-operations or supplemental fixation required to modify the device; and 3.) The incidence and severity of any psoas muscle injury, genital femoral nerve injury and lumbar plexus injury will be determined for all patients. Supplemental fixation of any kind may be included as long as the procedure is completed via a minimally invasive approach.

Conditions

Timeline

Start date: 2014-06-01
Primary completion: 2019-09-11
Completion: 2020-02-28
First posted: 2014-02-21
Last updated: 2021-04-05
Results posted: 2021-04-05

Source: ClinicalTrials.gov record NCT02068729. Inclusion in this directory is not an endorsement.