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Spine Center Clinical Trials

Clinical trials offer patients access to the latest therapies and help researchers find better ways to treat disease. The Johns Hopkins Neurosurgical Spine Center experts lead, co-lead or serve as clinical site supervisors for several clinical trials. For more information on these and other clinical trials, please visit the Johns Hopkins clinical trials database.

Explore clinical trial opportunities available at the Johns Hopkins Neurosurgical Spine Center:

Spinal Oncology Clinical Trials

Metastatic Tumor Research and Outcomes Network (MTRON)

Lead Site Investigator: Daniel M. Sciubba
Sponsor: AOSpine International
Clinical Trial Number: NCT02830451

The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).

Primary Tumor Research and Outcome Network (PTRON)

Lead Site Investigator: Chetan Bettegowda
Sponsor: AOSpine International
Clinical Trial Number: NCT02790983

Clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients will be collected and evaluated to investigate the prognostic factors which influence survival, local recurrence, adverse events, perioperative morbidity, and HRQOL in subgroups of patients diagnosed with primary spinal column tumors.

Other Spine Clinical Trials

Nivolumab With or Without Stereotactic Radiosurgery in Treating Patients with Recurrent, Advanced, or Metastatic Chordoma

Investigators: Lawrence Kleinberg, Kristin Redmond, Chetan Bettegowda
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, National Cancer Institute, Bristol-Myers Squibb, Chordoma Foundation
Clinical Trial Number: NCT02989636

This phase I trial studies the side effects of nivolumab with or without stereotactic radiosurgery (SRS) in treating patients with chordoma that has come back or spread from where it started to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab with or without stereotactic radiosurgery may work better in treating patients with chordoma.

Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study

Investigators: Daniel M. Sciubba, Khaled Kebaish, Brian Neuman
Sponsor: International Spine Study Group, DePuy Spine
Clinical Trial Number: NCT01588054

This is a multi-center, prospective, observational study to define clinical and demographic features of the population afflicted with cervical deformity (e.g., age, gender, comorbidities, disability, health related quality of life) and to assess for correlations between radiographic parameters and degree of disability/pain at baseline. We also aim to assess and describe surgical strategies used to address cervical deformity, define complications and rates of complications (perioperative and delayed) associated with the surgical treatment of cervical deformity and assess of the role/need for pre/post-operative tracheostomy and PEG. Lastly, we wish to identify risk factors related to poor clinical outcomes and define potential impact of complications on clinical/radiographic outcomes.

Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

Investigators: Khaled Kebaish, Daniel M. Sciubba, David Cohen
Sponsor: DePuy Spine, K2M, NuVasive, Zimmer Biomet, Orthofix
Clinical Trial Number: NCT00738439

Compared to adolescent idiopathic scoliosis, operative treatment of adult scoliosis is associated with higher complication rates, prolonged recovery time, and greater economic cost. Postoperative outcomes are often compromised by complications and revision surgery. Consequently, physicians must carefully weigh the risk/benefit ratio when deciding upon operative or nonoperative treatment of adult scoliosis. There is little data currently available that considers age stratification of adult deformity patients treated operatively versus nonoperatively and followed over a period of time as regards clinical and radiographic outcomes. Few reports have alluded to the increased risk of complications in patients over 65 years of age undergoing surgery. To date, no guidelines exist to stratify or score the risk benefit ratio that will produce an algorithm for treatment. Little data exists regarding indications for limited decompression versus decompression and stabilization for adult degenerative scoliosis. Conventional wisdom has guided operative approach selection for these patients. However, the operative morbidity is significantly higher in the stabilization procedures; therefore, tailoring the operative approach to the patient needs and presentation will guide surgeons in selective operative techniques for this adult degenerative scoliosis patient with deformity and stenosis.

As cost containment and Medicare cost cutting has become an area of increasing importance, functional outcome measures will help payers and CMS in coverage determination for adult deformity surgery. In this vein the guidelines or algorithm will help choose the most optimal treatment approach with the lowest complication rate for a particular problem. Answers to these questions will also better guide surgeons, help counsel patients and 3rd party payers on benefits of surgery vs. non-surgery for the different adult age groups and diagnostic categories.

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