Retrospective Chart Review to Assess Outcomes in Subjects That Received MAGNIFUSE® in the Posterolateral Lumbar Spine

Completed

• Conditions: Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine

• Registration Number: NCT02684045
• Lead Sponsor: Medtronic Spinal and Biologics

Brief Summary

The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Study Start: 2017-03-01
• Status Verified: 2017-08
• Primary Completion: 2017-08-15
• Study Completion: 2017-08-15
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

A subject's medical record must contain the following for the subject to be included:

1. Posterolateral surgical procedure using MAGNlFUSE with local autograft and/or iliac crest bone graft at one or two continuous lumbar levels from L1-S1.
2. Radiographs available for fusion assessment by clinician at 12 and/or 24 month post-surgery visits.
3. Subject must be at least 18 years old at the time of index procedure.

Exclusion Criteria

The subject data will be excluded from this study if the medical record indicates:

1. Additional surgical treatment adjacent to the initial lumbar levels treated per Inclusion Criterion 1.
2. Infection at index level(s) at time of surgery.
3. Extant tumor (evident at any level), spinal metastasis, or spinal tumor at the time of surgery.
4. Pregnant at time of surgery.
5. Surgery is due to trauma (e.g., motor vehicle accident or high impact fall).
6. Use of growth factors or growth peptide (BMP2, BMP7, or iFactor) in the index-level fusion surgery.
7. Procedure is a revision surgery for previously failed fusion at the surgery index level(s).
8. Subjects with body mass index > 40 at the time of surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion status at 12 or 24 months	12 or 24 months	Fusion status will be assessed using the Lenke posterior fusion criteria below: * Grade I: Solid trabeculated transverse process and facet fusions bilaterally.; * Grade II: Thick fusion mass on one side, and difficult to visualize on the other side.; * Grade III: Suspected lucency or defect in the fusion mass.; * Grade IV: Definite resorption of graft with fatigue of instrumentation.

Secondary Outcome Measures

Name	Time	Method
Back pain and leg pain measured by visual analog scale (VAS)	12 or 24 months
Pain and Disability status measured by Oswestry Disability Index (ODI)	12 or 24 months
Quality of life measured by EQ-5D	12 or 24 months

Trial Locations

Locations (2)

Midwest Ortho. Center; 🇺🇸 Peoria, Illinois, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States