Purpose of the Study
Compare outcomes between conventional navigation and augmented reality assisted navigation.

Eligibility Criteria

• Patients aged 20-80 years old.
• All patients presenting to the Wexner Medical Center and scheduled for the following surgeries as per the PI’s decision:
  • Deformative spine surgeries
  • Surgeries involving spinal segments T4 to Pelvis
  • Thoracolumbar degenerative surgeries
• Physically and mentally able and willing to comply with the protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
• The single spine surgeon operating on subjects in this study.

Study Status: Currently enrolling

Principal Investigator: Varun Singh

Contact: Nazihah Bhatti
Clinical Research Coordinator
at (614) 293-9785 or Nazihah.bhatti@osumc.edu

Funding/Study Sponsor: None

Purpose of the Study
The purpose of the study is to examine the use of cervical interf acet spaces. The study will assess f usion rates and cervical sagittal parameters f ollowing posterior cervical arthrodesis procedures supplemented with cervical interf acet spacers.

Description
This is a prospective study of patients undergoing posterior cervical arthrodesis procedures for spondylosis supplemented with cervical interfacet spaces (CIS) involving three or more segmental levels between C2 and upper thoracic. The primary outcome includes rate of cervical fusion and cervical sagittal alignment measured on post-operative radiographs.

Eligibility Criteria
Patients ≥ 18 years old with symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis between C2 and upper thoracic and no traumatic injury or severe co-morbidities. Other eligibility and exclusion criteria apply.

Study Status: Open to accrual

Principal Investigator: Andrew Grossbach, MD

Contact: Edouard Belizaire, B.S.
Clinical Research Assistant

Phone: 614-366-6936

Email: Edouard.Belizaire@osumc.edu

Funding/Study Sponsor: Ohio State

Purpose of the Study
The purpose of this post-markt, prospective, multicenter observational registry to assess the clinical safety and of Conduit™ Interbody Platform /EIT Cellular Titanium® (Conduit/EIT) in subjects who undergo interbody fusion surgery.

Description
This is a post-market, prospective, multicenter observational registry to assess the clinical safety and performance of Conduit™ Interbody Platform /EIT Cellular Titanium® (Conduit/EIT) in subjects who undergo interbody fusion surgery. Participants enrolled will be followed for a minimum of 12months and up to 24 months after surgery.

Eligibility Criteria
Patients who are ≥18 years of age who have been unresponsive to conservative care for a minimum of 6 months and are scheduled to have spinal fusion surgery with Conduit/EIT cages. Other eligibility and exclusion criteria apply.

Study Status: Open to accrual

Principal Investigator: Andrew Grossbach, MD

Contact: Allison Garvin, BS
Clinical Research Coordinator

Phone: 614-688-8304

Email: Allison.Garvin@osumc.edu

Funding/Study Sponsor: DePuy Synthes Spine, Inc.

Purpose of the Study
The aim of this study is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM. This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.

Description
This is a prospective, single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis. 58 Patients undergoing 3 to 4 level ACDF procedures from C2-T1 will be enrolled. Patients will be implanted with DePuy Conduit Titanium ACDF cage (DePuy Synthes, Raynham, MA). The primary outcome measures fusion rate at 6month, 12 month and 24- month.

Eligibility Criteria
Patients who are ≥18 years of age with symptomatic multi-level degenerative cervical spondylosis necessitating anterior cervical arthrodesis in the subaxial cervical spine (between C2-T1). Other eligibility and exclusion criteria apply.

Study Status: Open to accrual

Principal Investigator: Andrew Grossbach, MD

Contact: Allison Garvin, BS
Clinical Research Coordinator

Phone: 614-688-8304

Email: Allison.Garvin@osumc.edu

Funding/Study Sponsor: Ohio State

Purpose of the Study
The purpose of this global, multicenter, prospective, non-randomized, non-blinded, post-market, interventional study is to establish an extensive data repository allowing the sponsor to obtain collect performance and safety data on Medtronic post-market cranial & spinal technologies (CST) devices.

Description
Global, Multicenter, Prospective, Non-randomized, Non-blinded, Interventional, Post-market, clinical study with an extensible design following devices that are already commercialized and allowing new devices to be easily added following market release. Subjects are enrolled and followed postoperatively for up to 24 months.

Eligibility Criteria
Patients who are ≥18 years of age who are intended to be treated with an eligible Medtronic CST device willing to provide informed consent and are willing to complete all required assessments. Other eligibility and exclusion criteria apply.

Additional study information: https://clinicaltrials.gov/study/NCT05856370

Study Status: Open to accrual

Principal Investigator: Stephanus Viljoen, MD

Contact: Allison Garvin, BS
Clinical Research Coordinator

Phone: 614-688-8304

Email: Allison.Garvin@osumc.edu

Funding/Study Sponsor: Medtronic, Inc.

Purpose of the Study
The primary objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).

Description
This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery. The primary endpoints are the rate of complication attributable to use of the associated interbody implant and the proportion of subjects with radiographic fusion at 24 months post-surgery.

Eligibility Criteria
Patients who are ≥18 years of age with planned spine surgery using interbody implants and willing to provide informed consent. Other eligibility and exclusion criteria apply.

Additional study information: https://clinicaltrials.gov/study/NCT04418830

Study Status: Open to accrual

Principal Investigator: David Xu, MD

Contact: Allison Garvin, BS
Clinical Research Coordinator

Phone: 614-688-8304

Email: Allison.Garvin@osumc.edu

Funding/Study Sponsor: NuVasive

The purpose of the study includes:

• Obtaining safety and effectiveness data on the investigational device for multi-level PLF procedures
• Assessing immunological response via antibody testing pre- and post-operatively

Description
This is a prospective, randomized, multi-center, open-label study of the safety and effectiveness of the use of Infuse Bone Graft in multi-level PLF procedures and is intended to provide supporting evidence for a premarket approval (PMA) application.

The primary study objective is to assess fusion success at each treated level determined by radiographic assessment at 12 months. The secondary objectives are to obtain additional data on the investigational device for multi-level PLF procedures and to assess outcomes endpoints:

Eligibility Criteria
Patients ≥21 years of age with degenerative lumbar spine condition who have failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) and are willing and able to provide informed consent. Other eligibility and exclusion criteria apply.

Additional study information: https://clinicaltrials.gov/study/NCT03118505

Study Status: Open to accrual

Principal Investigator: David Xu, MD

Contact: Aladdin AlQaisi, MSc, CCRP
Sr. Clinical Research Coordinator

Phone: 614-814-7007

Email: Aladdin.Alqaisi@osumc.edu

Funding/Study Sponsor: Medtronic Spine

Purpose of the Study
The purpose of this post-markt, prospective, multicenter observational registry to assess the clinical safety and of Conduit™ Interbody Platform /EIT Cellular Titanium® (Conduit/EIT) in subjects who undergo interbody fusion surgery.

Description
This is a post-market, prospective, multicenter observational registry to assess the clinical safety and performance of Conduit™ Interbody Platform /EIT Cellular Titanium® (Conduit/EIT) in subjects who undergo interbody fusion surgery. Participants enrolled will be followed for a minimum of 12months and up to 24 months after surgery.

Eligibility Criteria
Patients who are ≥18 years of age who have been unresponsive to conservative care for a minimum of 6 months and are scheduled to have spinal fusion surgery with Conduit/EIT cages. Other eligibility and exclusion criteria apply.

Study Status: Open to accrual

Principal Investigator: Andrew Grossbach, MD

Contact: Allison Garvin, BS
Clinical Research Coordinator

Phone: 614-688-8304

Email: Allison.Garvin@osumc.edu

Funding/Study Sponsor: DePuy Synthes Spine, Inc.

Purpose of the Study
To determine factors (clinical, radiographic and/or biodynamic) associated with proximal junctional kyphosis and failure after long segment thoracolumbar fusion.

Description
This is a prospective study of patients with symptomatic spinal deformity undergoing a long segment fusion. One hundred patients will be enrolled and followed for 5 years. Serial objective clinical, and radiographic data will be collected from medical records and biodynamic measures will be obtained to achieve the primary and secondary objectives.

Eligibility: n/a

Inclusion:

• At least age 18
• Radiographic evidence of spinal deformity.
  • Based on Schwab criteria for adult spinal deformity at least one coronal curve (thoracic, lumbar, or double major curve greater than 30 degrees) or at least two sagittal modifiers (abnormal sagittal vertical axis, pelvic incidence lumbar lordosis mismatch, elevated pelvic tilt).
• Unresponsive to non-operative management for 6 weeks or progressive symptoms or signs of nerve root spinal cord compression.

Exclusion:

• Non-English speakers, prisoners, patients with cognitive deficits
• Previous cervical trauma resulting in fracture or disco-ligamentous injury.
• Rheumatoid arthritis or other musculoskeletal autoimmune disorders.
• Malignancy.
• Morbid obesity.
• Active infections

Study Status: Open to accrual

Principal Investigator: Stephanus Viljoen, MD

Contact: Allison Garvin, BS
Clinical Research Coordinator

Phone: 614-688-8304

Email: Allison.Garvin@osumc.edu

Funding/Study Sponsor: Ohio State

Purpose of the Study
Characterize immune cells in degenerate human surgical tissue samples

Eligibility Criteria

• Subjects undergoing procedures involving the removal of the intervertebral disc and facet joint cartilage

Study Status: Currently enrolling

Principal Investigator: Devina Purmessur, PhD

Contact: Justin Richards
Clinical Research Coordinator
Justin.richards@osumc.edu

Funding/Study Sponsor: None

Purpose of the Study
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Medtronic Adaptix™ cage with roughened micro and nano-textured titanium surfaces or the CAPSTONE® poly-ether-ether-ketone cage.

Description
The randomized controlled trial will prospectively evaluate the efficacy of Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system as compared to a Medtronic CAPSTONE® PEEK cage currently used in routine fashion for lumbar interbody fusion procedures. This study will capture clinical and radiographic outcomes on patients up to 2 years post-operatively.

Eligibility Criteria
Patients who are >18 years of age who have been unresponsive to conservative care for a minimum of 6 months and are scheduled to undergo combined interbody and posterolateral spinal fusion. Other eligibility and exclusion criteria apply.

Study Status: Open to accrual

Principal Investigator: Andrew Grossbach, MD

Contact: Allison Garvin, BS
Clinical Research Coordinator

Phone: 614-688-8304

Email: Allison.Garvin@osumc.edu

Funding/Study Sponsor: Ohio State

Purpose of the Study
The purpose of this global, multicenter, prospective, non-randomized, non-blinded, post-market, interventional study is to establish an extensive data repository allowing the sponsor to obtain collect performance and safety data on Medtronic post-market cranial & spinal technologies (CST) devices.

Description
Global, Multicenter, Prospective, Non-randomized, Non-blinded, Interventional, Post-market, clinical study with an extensible design following devices that are already commercialized and allowing new devices to be easily added following market release. Subjects are enrolled and followed postoperatively for up to 24 months.

Eligibility Criteria
Patients who are ≥18 years of age who are intended to be treated with an eligible Medtronic CST device willing to provide informed consent and are willing to complete all required assessments. Other eligibility and exclusion criteria apply.

Additional study information: https://clinicaltrials.gov/study/NCT05856370

Study Status: Open to accrual

Principal Investigator: Stephanus Viljoen, MD

Contact: Allison Garvin, BS
Clinical Research Coordinator

Phone: 614-688-8304

Email: Allison.Garvin@osumc.edu

Funding/Study Sponsor: Medtronic, Inc.

Purpose of the Study
Evaluate the safety and effectiveness of the investigational treatment as compared to control and to obtain indication expansion for Infuse™ use in one and two level TLIF procedures.

Description
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. This study will examine the safety and effectiveness of 2.1 mg and 4.2 mg of rhBMP-2 per operative level. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months and endpoint success will also be determined at 24 months postoperatively.

Eligibility Criteria
Patients ≥18 years of age with degenerative disease of lumbosacral spine who have failed ≥6 months non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) and are willing and able to provide informed consent. Other eligibility and exclusion criteria apply.

Additional study information: https://clinicaltrials.gov/study/NCT04073563

Study Status: Open to accrual

Principal Investigator: Stephanus Viljoen, MD

Contact: Aladdin AlQaisi, MSc, CCRP
Sr. Clinical Research Coordinator

Phone: 614-814-7007

Email: Aladdin.Alqaisi@osumc.edu

Funding/Study Sponsor: Medtronic Spine

Goal and Background: 

Nerve fiber outgrowth after spinal cord injury in hindered by molecular stop signs in its environment. Blocking those stop signs is one way to foster nerve growth as a basis to promote. This trial is among the first-generation studies to test plasticity-enhancing interventions in spinal cord injury.

Study Link

https://clinicaltrials.gov/ct2/show/NCT03989440?term=jan+schwab&draw=2&rank=3

Contact

Amy Bartlett, BA, CCRC       

Phone: 6143669050

Email: amy.bartlett@osumc.edu

Principal Investigator: Jan Schwab, MD, PhD

Purpose of the Study
The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury.

Description
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of MT-3921 in subjects with acute traumatic cervical SCI. All eligible subjects will receive 25 mg/kg MT-3921 or placebo intravenously on Day 1 and Day 15, then once per month from Day 30 to Day 150. The study duration is approximately 9 months: screening period up to 2 days after SCI, 6-month double-blind period, and 3-month follow-up period.

Eligibility Criteria
Cervical SCI Patients 18 – 75 years old with ISNCSCI neurological level of injury between C4 and C7 classified as AIS A, AIS B or AIS C. Other eligibility and exclusion criteria apply.

Additional study information: https://clinicaltrials.gov/study/NCT04683848

Study Status: Open to accrual

Principal Investigator: David Xu, MD

Contact: Aladdin AlQaisi, MSc, CCRP
Sr. Clinical Research Coordinator

Phone: 614-814-7007

Email: Aladdin.Alqaisi@osumc.edu

Funding/Study Sponsor: Mitsubishi Tanabe Pharma America, Inc.

Goal and Background: 

Infections are the main cause of death after acute and chronic SCI. Becoming able to predict infections will provide the ability to treat infections before they occur as a means to reduce mortality and disability.

Study Link

https://clinicaltrials.gov/ct2/show/NCT03253952?term=jan+schwab&draw=2&rank=1

Contact

Aash Bhandari       

Phone:614-366-3877

Email:aash.bhandari@osumc.edu

Principal Investigator: Jan Schwab, MD, PhD

Goal and Background: 

Here, we collect data for the National Spinal Cord Injury Database. This is the world largest data repository with the long-term follow-up after spinal cord injury. This database has been instrumental to learn about the epidemiology and outcomes after spinal cord injury.

Study Link

https://www.nscisc.uab.edu

Purpose of the Study: To establish a prospective registry of validated outcome measures from patients treated at Ohio State Spine Care. The registry will provide the investigators an immediate internal database to prospectively track and report on the quality of both the non-surgical and surgical care (including the most common spinal procedures) provided at the OSUCSC.

Description: To establish a prospective registry of validated outcome measures from patients treated at OSUCSC. The registry will provide the investigators an immediate internal database to prospectively track and report on the quality of both the non-surgical and surgical care (including the most common spinal procedures) provided at the OSUCSC.

Specifically, this registry will:

• Allow for comparison of validated outcomes at the OSUCSC against established risk-adjusted national quality benchmarks for common spinal procedures
• Allow OSU practitioners to review their own individual morbidity and clinical outcomes in real-time
• Generate both quality and efficiency data with respect to spinal procedures
• Assess the comparative effectiveness of spinal procedures
• Generate comparative cost data for non-operative versus operative care of common spinal conditions
• Allow for gathering of relevant information for potential future spine-related research use. This research may include multi-center trials and other cooperative clinical studies. Any future research projects using data from this database will be submitted to the OSU Institutional Review Board (IRB) for their own separate IRB approvals.

Eligibility Criteria: We will include any patient that presents to the OSUCSC for evaluation. Patients may go on to receive conservative care or pursue surgical options for treatment. There is not an experimental treatment involved with this registry. This registry is collecting information regarding patients’ natural, standard course of care. Patients will be excluded if they do not speak English, have cognitive disabilities which may impact their capacity to provide informed consent, or are a prisoner.

Study Status: Approved, not yet recruiting

Principal Investigator: Albert Timperman, MD

Contact: Kathy Jelinek, Clinical Research Manager, Kathryn.Jelinek@osumc.edu

Funding/Study Sponsor: OSUWMC