Spine Center Clinical Trials

If you would like to participate in a clinical trial at Johns Hopkins, please go to the  clinical trial database (ITCR), for more information.

Study Title: NA_00023202

Principal Investigator: Chetan Bettagowda, MD

Summary: Physicians at the Johns Hopkins Hospital are participating in a FDA approved clinical trial that is testing a novel therapy for patients with recurrent chordoma, a rare spine tumor.

C. novyi-NT is currently in an FDA sanctioned phase I clinical trial at the Johns Hopkins Hospital. Chordomas are thought to be very hypoxic and this could be part of the reason why standard chemotherapies have historically failed in chordoma patients. We are currently enrolling patients to understand how people with recurrent chordomas arising in the sacrum respond to this therapy.

Recruiting Status: Open

For more information, please contact Dr. Charles Rudin at 410.955.8893

Learn about Hypoxia Targeting Therapy for Chordomas

Study Title: NA_00036459: CSSG Multi Center Retrospective and Observational Data Registry for Clinical and Radiographic Outcomes of Complex Spine Surgeries

Principal Investigator: Daniel Sciubba, MD

Summary: The purpose of this study is to collect information for a research database from subjects with spinal disease and deformity. This will be called the “Complex Spine Study Group (CSSG) Database.” This database will be used to help with research in the future.

The Complex Spine Study Group database is designed to develop a better understanding of spinal disease and deformities, and how they have responded to various forms of treatment and interventions. Spinal disease and deformities are caused by many different conditions, but involve abnormal alignment of the spine.

Recruiting Status: Open

Study Title: NA_00038361: Retrospective Study of Sacrectomies

Principal Investigator: Jean-Paul Wolinsky, MD

Summary: Retrospective review of all sacrectomies performed at Johns Hopkins Hospital between 2004 and present. This will be a chart review of approximately 75 patients who have been operate by the PI's and who are routinely followed as clinical patients. Preoperative characteristics including demographics (age/sex), medical comorbidities, preoperative tumor type and treatment (biopsy, adjuvant therapy, previous surgery), operative markers (surgery type, time, blood loss etc.), immediate postoperative metrics (LOS, disposition, complications, ICU stay etc.), post-operative adjuvant therapy, and long-term outcomes (including complications, disease status and lifespan will be assessed).

Recruiting Status: Open

Study Title: NA_00048390: Efficacy of Riluzole in Patients with Cervical Spondylotic Myelopathy (CSM) Undergoing Surgical Treatment. A Multi-Center Double Blind Randomized Controlled Trial

Principal Investigator: Daniel Sciubba, MD

Summary: The purpose of this study is to determine the neuroprotective effectiveness of Riluzole compared to placebo in subjects with CSM undergoing surgical treatment. CSM is the most common cause of spinal cord injury worldwide. CSM is a narrowing of the spinal canal in the neck. Compression makes the blood supply too low and cells die. There is evidence that surgery to decompress the spinal cord is a good treatment for CSM but approximately 3% of patients have serious neurological injury. The goal of this study is to see if treating patients with Riluzole will aid in the protection of the spinal cord.

Recruiting Status: Open

Study Title: NA_00048835: National Neurosurgery Quality and Outcomes Database (N2QOD)

Principal Investigator: Ali Bydon, MD

Summary: To date, no nationally collaborative reporting mechanisms utilizing validated quality and outcome measures have assessed 1) to what extent lumbar spinal surgery improves pain, disability, and quality of life and 2) what incidence of morbidity is acceptable after lumbar surgery adjusting for biasing and influential confounders; including variances in co-morbidity, surgical approach, cultural, region, structure and process of health services. Hence, risk-adjusted benchmarks of surgical morbidity and effectiveness, which define spine surgical quality, have yet to be determined. Without a robust quality improvement networking platform, benchmarks of acceptable quality of care cannot be accurately assessed and practice groups cannot accurately determine areas of their practice where quality improvement should be targeted.

Recruiting Status: Open

Study Title: NA_00066200: Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine: A Multi-center Retrospective Cohort Study with a Cross-Sectional Survival Check

Principal Investigator: Ziya Gokaslan, MD

Summary: The purpose of this study is to determine clinical, imaging and treatment factors that influence patient survival, local recurrence rate, and peri-operative/post-operative morbidity. Most surgical options carry significant morbidity and consume vast resources. In contrast, there is emerging evidence that incomplete or oncologically inappropriate resection increases local recurrence rate and decreases overall survival. This data will be used to refine existing study questions regarding patient outcomes and to develop new study questions that will be assessed in the future using prospectively collected data.

Recruiting Status: Open