Clinical Trials

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SOLAS® Spinal Surgery Registry: Prospective Clinical and Radiographic Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients
The SOLAS Spinal Surgery Registry is a prospective multi-center observational data collection initiative, to capture clinical and radiographic outcomes in candidates for spine surgery with degenerative, deformity, and traumatic pathologies. As an observational database, there are no initial driving hypotheses, but rather data will be mined to answer unforeseen questions, but which may include broad topics such as comparative effectiveness between and among various surgical treatment options, and/or outcomes in various subgroups of patients such as defined by demographics, comorbidities, indications and symptoms, treatment variables, and/or outcome variables.
(REF# 3361)

National Neurosurgery Quality and Outcomes Database (N2QOD): A Prospective Registry for Quality Reporting
The purpose of this national outcomes database is to assess to what extent lumbar spinal surgery improves pain, disability, and quality of life. To date, no nationally collaborative reporting mechanisms utilizing validated outcome measures have assessed lumbar spinal surgery outcomes. (REF# 29554)

Using Mobile Phone Text Messaging and E-mailing to Decrease Anxiety, Pain, Follow-up Visits and Improve Reporting of Surgical Site Infection after Spine Surgery: A Double-Blind Randomized Trial
The objectives of this double-blind, randomized controlled study are to evaluate the efficacy of maintaining contact with low-back pain patients through text messaging and emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging and emailing, and to improve reporting of surgical site infection after spine surgery through text messaging and emailing. (REF# 34182)

Multimodality Neuromonitoring in XLIF (NV in XLIF®)
This is a prospective, non-randomized multi-center study to evaluate intraoperative neuromonitoring results in subjects who undergo extreme lateral interbody fusion (XLIF) surgery at any number of levels inclusive of L4-5. (REF# 34204)

XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis
The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis. (REF# 22589)

Utilization of Conventional and Complimentary Healthcare Services by Professional, Student, and Amateur Dancers
The purpose of this study is to determine the health care needs of dancers, in order to design a Dancer Wellness and Dance Medicine Program at Duke Medical Center. (REF# 42965)

CSSG Multi-Center Retrospective and Observational Data Registry for Clinical and Radiographic Outcomes of Complex Spine Surgeries
The purpose of this national, multi-site study is to conduct a review of surgical spine procedures by multiple surgeons at participating centers. It is anticipated that this data registry may expand clinical knowledge of managing trauma patients, tumor patients, and spinal disease/deformity via complex spine surgical procedures, thus optimizing patient care.
(REF# 37459)

The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study
The purpose of this randomized study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery. (REF# 40054)