rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

Stopped early · Phase 4

Conditions studied: Lumbar Spine Degeneration

In brief

This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.

Key facts

Study ID

NCT03527966

Run by

Virtua Health, Inc.

People needed

3

Starts

2017-07-03

Expected to finish

2018-07-27

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 or older;
• Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc disease with axial low back pain and neurologic symptoms, failed conservative treatment and eligible for a single level lumbar instrumented fusion;
• Willing to provide informed consent, participate in study, and comply with study protocol.

You may not qualify if…

• Pregnant or contemplating pregnancy prior to surgery;
• Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
• Surgery involving more than 2 vertebral levels;
• Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests; could also run into potential issues with reimbursement).
• Lactating women
• Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin
• Immune compromised patients

Where it is running

• Virtua Memorial Hospital — Mount Holly, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.