Clinical Trials

Surgical Versus Non-Operative Treatment of Metastatic Epidural Spinal Cord Compression (MESCC) -- Quality of Life and Cost-Effectiveness Outcomes

JHMI IRB #NA_00013681

Metastatic epidural spinal cord compression (MESCC) occurs due to a metastatic growth of tissue in the epidural space. This tissue growth may cause neurological compromise, either by physical pressure on the spinal cord or by impairment of spinal cord blood flow. MESCC is a serious and common condition in patients with cancer. Spinal cord compression develops in 5 - 10% of patients with cancer. MESCC is associated with pain, paralysis, loss of sensory function and loss of sphincter function.

Traditionally, the standard treatment approach in MESCC has been radiation therapy and corticosteroids. Over the past decade, patients have been increasingly treated with surgery, primarily in cases when there is spinal instability, progressive neurological dysfunction or a failure of radiotherapy.

The purpose of this study is to evaluate the differences in pain relief, neurological function, quality of life, and survival in patients with metastatic epidural spinal cord compression who are managed with a combination of surgery and radiotherapy compared to radiotherapy alone.

For more information, please contact
Barbara Levit at 410.502.6103

Randomized Controlled Trial of Duragen Plus Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy

JHMI IRB# NA_00004894
Principal Investigator: Dr. Timothy Witham

The purpose of this study is to evaluate the effectiveness, safety and performance of DuraGen Plus Adhesion Barrier Matrix, an investigational device used for the purpose of preventing or minimizing adhesions or scares that may develop after operations on the spine.

This clinical trial is being undertaken to evaluate the ability of DuraGen Plus Adhesion Barrier Matric to minimize post-surgical perineural scarring or peridural fibrosis and to reduce radicular pain following surgical procedures involving lumbar hemi-laminectory or hemi-laminotomy with discectomy compared to a control group receiving standard care.

Things to Consider:  Women who are nursing, pregnant or planning to become pregnant during the time of the study are excluded from this study as are patients with a current or historic open traumatic spinal injury.

For more information, please contact
Barbara Levitl at 410.502.6103