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Clinical Research

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Clinical Research

Northwest Specialty’s Clinical Research Team is proud to be driving medical research that changes local lives.
And we’re doing it right here, in our North Idaho community.

Ongoing Studies

M6-C with Orthofix

– Dr. Roland Kent

This study is seeking patients with degenerative cervical radiculopathy requiring
surgical intervention, confirmed clinically and radiographically, at two contiguous
vertebral levels from C3 to C7.

The primary objective of the study is to evaluate the safety and effectiveness of the
Orthofix M6-C™ artificial cervical disc in patients with contiguous two-level
symptomatic cervical radiculopathy with or without cord compression.

You may be eligible for the study if:

  • Have been told you need neck surgery at two adjacent levels between C3 to C7.
  • Are experiencing neck and/or arm pain after at least 6 weeks of conservative, non-surgical treatment.
  • Are willing and able to attend follow-up progress visits with your doctor over 24 months and possibly 5 years.
  • Do not have any autoimmune disorders, cancer, and not insulin-dependent diabetic.
  • BMI < 45.
  • Are between 18 years and 75 years of age.

Learn More Here.

CATAMARAN SI Joint Fusion System

The Catamaran® SI Joint Fusion System offers a novel, less invasive Inferior-Posterior approach to the SI joint using a single, robust titanium implant.

The System features the Catamaran® Fixation Device, which passes through both the axial and sagittal planes of the ilium and sacrum, transfixing the SI joint along its longitudinal axis.

Early clinical experience has shown that the Catamaran® SI Joint Fixation Device via an inferior-posterior approach has the potential to deliver significant & sustained reduction in SI joint pain, as well as:

  • Minimal blood loss & fluoroscopy time
  • Reduced post-op pain
  • Rapid reduction in pain medications
  • Insertion pathway away from neural and vascular structures

Learn More Here.

Visit the Website.

COMPASS by Carlsmed

– Dr. Roland Kent

COMPaSS, Clinical Outcome Measures in Personalized aprevo® Spine Surgery, is a multi-center post market prospective observational registry. The study will collect data on patients with degenerative spinal conditions and are treated surgically with Carlsmed aprevo devices and will track outcomes for a period of two years.

Learn More Here.

SCOPE by Boston Scientific

A clinical research study is underway to better understand real-world outcomes of the Vertiflex® Procedure uses the Superion® Indirect Decompression System (IDS), a medical device approved for commercial use by the Food and Drug Administration (FDA) in the United States for treatment of moderate lumber spinal stenosis.

You may be eligible for the study if:

  • 45 years of age or older.
  • Have a primary pain complaint of leg/buttock/groin pain, with or without back pain that is relieved by flexion activities (example: sitting or bending over a shopping cart).
  • Diagnosis of degenerative spinal stenosis of the lumbar spine.
  • Provide written informed consent prior to enrollment.

Learn More Here.

NEVRO HFX™

– Dr. Jessica Jameson

Do you suffer from pain and loss of sensation in your feet or legs due to diabetic neuropathy?

You may be eligible to participate in a clinical trial to evaluate Nevro HFX™ as a treatment for your painful diabetic neuropathy.

You may be eligible for the study if:

  • Have you been diagnosed with painful diabetic neuropathy of the feet and/or legs?
  • Do you have partial or full loss of sensation in your feet?
  • Have you tried standard treatment approaches?
  • Will you be 22 years of age or older at the time of enrollment?
  • Are you able to attend study visits at Northwest Specialty Hospital and AXIS Spine Center?

Learn More Here.

Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery (KIPSs)

– Dr. Jessica Jameson

This study was written by our very own Jessica Jameson, MD and Elisa Maples, BS, CCRC, ACRP-PM. We were awarded funds from the Idaho Panhandle Health Opioid Settlement Fund to create and run this exciting study

This study seeks to determine if a pre-operative ketamine infusion would provide a similar decrease in post-operative analgesic and opioid consumption as intra-operative ketamine, but expand the monitoring period through the post-operative phase up to 90 days. The hypothesis is that pre-operative ketamine infusion will lead to a decrease in narcotic consumption from baseline following an elective cervical or lumbar fusion, leading to increased functionality and quality of life for patients.

You may be eligible for the study if:

  • Male or female, aged 18-75
  • Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Daily opiate use totaling ≥50 morphine milli-equivalents (MME) or more for 6 weeks or greater
  • Scheduled for revision surgical fusion of the cervical or lumbar spine
  • Total duration of neck or back pain >12 weeks

Learn More Here.

Completed Studies

RESET Back Pain Study (No Longer Enrolling)

– Dr. Jessica Jameson

The breakthrough treatment designed to provide sustained relief from chronic pain.

SPRINT is a 60-day treatment designed to provide sustained pain relief:
•Minimally-invasive, non-surgical
•Nerve-sparing
•Non-opioid, drug-free
•No permanent implant

Brochure

Learn More

Total Posterior Spine (TOPS)

– Dr. Roland Kent

Northwest Specialty Hospital Clinical Research and Dr. Roland Kent are proud to have been an integral part of this pivotal IDE study, and have been so fortunate to watch the impact this groundbreaking device has had on the patients in our community.

TOPS, by PREMIA Spine is a revolutionary new lumber facet replacement device that is now FDA approved. Dr. Kent was one of the pioneering doctors in the United States to test this device.

Learn More Here.

Read the TOPS Study Here.

Elisa Maples, BS, CCRC, ACRP-PM

Clinical Research Director

Northwest Specialty Hospital Clinical Research

nwsh.research@nwsh.com

(208) 664-0290

Jennifer Natarajan, CRC

Clinical Research

Northwest Specialty Hospital Clinical Research

nwsh.research@nwsh.com

(208) 500-2854

Katie Chemodurow, CRC

Clinical Research

Northwest Specialty Hospital Clinical Research

nwsh.research@nwsh.com

(208) 664-0291

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