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

Medtronic

Status: Completed

Conditions: Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine

Study type: Observational

Funder types: Industry

Identifiers

NCT02684045

P15-03

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Volunteers: No Healthy Volunteers

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.