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

A Retrospective Review of Charts to Assess Outcomes in Subjects That Received MAGNIFUSE® DBM in the Posterolateral Lumbar Spine

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.

Study Overview

• Status: Completed
• Conditions: Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Midwest Ortho. Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who underwent a posterolateral surgical procedure with MAGNIFUSE in the lumbar spine.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion status at 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.	12 or 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
complications of interest	12 or 24 months

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): August 15, 2017
• Study Completion (Actual): August 15, 2017

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: P15-03