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Neurology and Neurosurgery

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Spine Center Clinical Trials

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.

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).

The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)

Lead Site Investigator: Daniel M. Sciubba

Sponsors: AOSpine International, Orthopaedic Research Foundation

Clinical Trial Number: NCT01825161

The main purpose of this study is to utilize a comprehensive, prospective clinical database to collect patient, diagnostic and treatment variables along with disease specific and generic health related quality of life (HRQOL) data on consecutively treated patients with metastatic spine tumors. The objectives are to determine the validity and reliability of the Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes, to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool for predicting the stability of spine in metastatic spine disease, and to determine the efficacy of surgery versus radiotherapy for the treatment of impending instability secondary to metastatic disease of the spine.

Primary Tumor Research and Outcome Network (PTRON)

Site Investigator: Daniel M. Sciubba, 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.

Radiotherapy for Solid Tumor Spine Metastases

Investigators: Kristin Redmond, Daniel M. Sciubba, Chetan Bettegowda, Michael Lim

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Clinical Trial Number: NCT01752036

This is a phase II trial evaluating the rate radiographic local recurrence following post-operative stereotactic radiosurgery boost in patients with metastatic solid malignancies with spine metastases status post resection. Patients will be treated with 600 cGy x 5 fractions to the tumor bed and then followed both clinically and radiographically to determine if local recurrence following this treatment is better than might be expected for conventional radiation therapy.

Other Spine Clinical Trials

Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis (I-Spondy)

Lead Site Investigator: Daniel M. Sciubba

Sponsor: AOSpine North America Research Network

Clinical Trial Number: NCT02564705

The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.

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

Investigators: Michael Lim, Daniel M. Sciubba, Kristin Redmond, Chetan Bettegowda, Sheng-Fu Lo

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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