Medtronic Device Follow-Up for Spinal Conditions

Recruiting at 22 trial locations

Overseen By Andrew Grossbach, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Spinal and Biologics

Disqualifiers: Concurrent trials, Inaccessible, Vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Index Surgery

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather data on the safety and effectiveness of Medtronic devices for people with spinal and cranial conditions. Participants will receive these devices and undergo monitoring for two years to ensure proper function and safety. The trial includes various types of spinal hardware, such as rods, screws, and imaging devices. It suits individuals scheduled to receive a Medtronic device for a spinal or cranial issue and willing to attend follow-up visits for two years. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these Medtronic devices are safe for spinal conditions?

Research has shown that Medtronic devices, such as those for spinal conditions, have generally been safe in past studies. For instance, spinal cord stimulation systems, a type of Medtronic device, help manage chronic pain. The FDA has approved these devices for certain conditions, indicating they have passed safety tests.

Although studies indicate these devices are usually well-tolerated, some risks exist. Common issues might include skin irritation or discomfort at the placement site. Avoiding activities that might stress the device is important.

Despite these risks, many patients have used these devices safely. Prospective participants should discuss any concerns with the study team or their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Medtronic's devices for spinal conditions because they offer a comprehensive approach by integrating advanced technologies like robotics, navigation, and imaging. These devices stand out from traditional treatments that often rely on basic hardware by providing enhanced precision and control during spinal surgeries. The combination of powered systems, advanced energy devices, and biologics aims to improve surgical outcomes and patient recovery times, potentially revolutionizing how spinal conditions are treated.

What evidence suggests that Medtronic devices are effective for spinal conditions?

Studies have shown that Medtronic's spinal cord stimulation devices can effectively reduce chronic pain. One study found that participants experienced an average of 67% less lower back pain after 12 months, with 87% reporting significant improvements in their condition. These devices help manage long-lasting nerve pain, providing ongoing relief. Research indicates that these devices are both safe and effective for treating spinal conditions. Participants in this trial will receive eligible Medtronic devices from various product groups to further evaluate their effectiveness and safety. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who need a Medtronic Cranial and Spinal Technology device for conditions like spinal tumors, scoliosis, or spinal trauma. Participants must give written consent, agree to follow-up assessments up to 24 months post-surgery, and not be in other trials that could affect results.

Inclusion Criteria

Subject agrees to complete all required assessments per the Schedule of Events

Subject provides written informed consent per institution and/or geographical requirements

Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s)

Exclusion Criteria

Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance)

Subject who is, or is expected to be, inaccessible for all required follow-up visits

Subject with exclusion criteria required by local law

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Medtronic devices for cranial and/or spinal indications and undergo surgery

Index Surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of surgical success, fusion success, and device performance

24 months

Long-term Follow-up

Continued monitoring of device performance and adverse events

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic devices

Trial Overview The study is tracking the performance and safety of Medtronic devices used in surgeries for various cranial and spinal issues. Patients will have routine clinical care data collected from before surgery until up to two years after the procedure.

How Is the Trial Designed?

Group I: Receiving eligible Medtronic device(s) from all product groups Experimental Treatment 1 Intervention

Powered Systems, Instruments, and Imaging device(s), Advanced Energy device(s), Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)

Medtronic devices is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Medtronic Neurostimulation Systems for:

• Chronic, intractable pain of the trunk and/or limbs
• Cranial procedures including tumor resections, cranial biopsies, general ventricular catheter placement, pediatric ventricular catheter placement, depth electrode, lead, and probe placement

Approved in European Union as Medtronic Neurostimulation Systems for:

• Chronic, intractable pain of the trunk and/or limbs
• Cranial procedures including tumor resections, cranial biopsies, general ventricular catheter placement, pediatric ventricular catheter placement, depth electrode, lead, and probe placement

Approved in Canada as Medtronic Spinal Cord Stimulation Devices for:

• Chronic, intractable pain of the trunk and/or limbs

Approved in Japan as Medtronic Cranial Devices for:

• Cranial procedures including tumor resections, cranial biopsies, general ventricular catheter placement, pediatric ventricular catheter placement, depth electrode, lead, and probe placement

Who Is Running the Clinical Trial?

Medtronic Spinal and Biologics

Lead Sponsor

Trials

56

Recruited

10,600+

Medtronic Cardiac Rhythm and Heart Failure

Industry Sponsor

Trials

206

Recruited

137,000+

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School

Medtronic Bakken Research Center

Industry Sponsor

Trials

98

Recruited

78,500+

Denise L. Blomquist

Medtronic Bakken Research Center

Chief Executive Officer

Bachelor's degree in Accounting from the University of Wisconsin - Madison

Dr. Kim Chaffin

Medtronic Bakken Research Center

Chief Medical Officer

MD

Published Research Related to This Trial

Spinal cord stimulation (SCS) is effective in improving pain relief, sleep quality, and functional activities in patients with chronic pain, as shown by a survey of 30 patients who reported positive outcomes after receiving different SCS devices.

While there were no significant differences in pain relief and sleep improvement among the three SCS device manufacturers (Medtronic, Advanced Bionics, and ANS), the Advanced Bionics group showed less functional improvement compared to the other two groups, suggesting that device technology may influence certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. Haddadan, K., Krames, ES.[2022]

In a study of patients with multiple sclerosis, primary lateral sclerosis, and hereditary spino-cerebellar disorders, 50% experienced lasting improvements in neurological function after spinal cord electrostimulation over a follow-up period of 15 to 27 months, particularly benefiting those with less severe disabilities.

Electrostimulation appears to enhance neurological function rather than cure the underlying disease, and it has shown more dramatic responses in patients with vasospastic disorders, suggesting it may serve as a supplementary treatment alongside standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrostimulation of the nervous system for patients with demyelinating and degenerative diseases of the nervous system and vascular diseases of the extremities. Dooley, DM., Sharkey, J.[2019]

Electrical stimulation of the spinal cord using the Pisces system showed dramatic improvements in motor function for five patients with motor neurone disease, although the disease progression was not halted in all cases.

Despite one patient experiencing initial improvement, two patients faced severe disease progression, highlighting the need for careful patient selection and further research into the long-term efficacy and safety of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pisces stimulation for motor neurone disease. Plotkin, R.[2019]

Spinal cord stimulation has evolved significantly over 25 years, with studies involving 1,336 cases across various motor disorders, demonstrating its effectiveness in conditions like cerebral palsy and spinal cord injury.

The therapeutic effects of spinal cord stimulation are influenced by specific parameters such as the spinal cord level targeted, field configuration, polarity, and stimulation frequency, highlighting the importance of tailored approaches for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a quarter century of development and investigation. A review of its development and effectiveness in 1,336 cases. Waltz, JM.[2018]

A study involving 31 patients with spinal cord stimulation (SCS) systems showed that undergoing MRI scans is generally safe, with no serious complications or harm reported during the procedure.

While some minor issues like increased temperature at the generator site and telemetry difficulties were noted, these did not affect patient safety or lead to reprogramming of the SCS systems, indicating that MRI can be performed safely in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in patients with spinal neurostimulation systems. De Andres, J., Valía, JC., Cerda-Olmedo, G., et al.[2007]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

In a study involving 16 patients who underwent a total of 72 MRI scans over 17 years, no negative effects on the function of InterStim™ sacral neurostimulator systems were observed, indicating that these devices can safely coexist with multiple MRI examinations.

Patients reported no pain or discomfort during or after the MRI scans, and assessments of the device's function showed no significant changes, confirming the safety and efficacy of the SNS even after repeated imaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple magnetic resonance imaging in patients with implanted sacral nerve stimulator. Heidler, S., Ostermann, S., Kuglitsch, M., et al.[2021]

In a global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

In a study of 420 patients with chronic back and/or leg pain, spinal cord stimulation (SCS) significantly reduced pain scores from an average of 7.2 to 2.4 after a mean follow-up of about 208 days, indicating strong efficacy in pain management.

The customizable nature of the SCS systems, which allowed for tailored neurostimulation programs based on patient feedback, suggests that personalized treatment approaches can enhance pain relief in real-world clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes. Metzger, CS., Hammond, MB., Pyles, ST., et al.[2020]

In a study of 22 patients with severe angina, spinal cord stimulation (SCS) significantly reduced the frequency of anginal attacks and the need for glyceryl trinitrate (GTN) over a 1-year follow-up, demonstrating its efficacy as an adjuvant therapy.

The method for adjusting SCS parameters was found to be feasible, with no significant changes in stimulation settings over the year for patients without lead dislocations, although 6 patients did experience lead dislocation requiring surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation characteristics, complications, and efficacy of spinal cord stimulation systems in patients with refractory angina: a prospective feasibility study. de Jongste, MJ., Nagelkerke, D., Hooyschuur, CM., et al.[2019]

Spinal cord stimulation (SCS) is an effective treatment for chronic pain, particularly in patients with refractory unilateral limb pain syndrome (RULPS), with an initial response rate of 87% that stabilizes at 84% after two years.

A significant portion of patients experienced benefits, including a reduction in pain medication (56%) and a return to work (46.8%), highlighting the importance of careful patient selection and follow-up for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for the treatment of refractory unilateral limb pain syndromes. Kumar, A., Felderhof, C., Eljamel, MS.[2017]

In a study of 44 patients with failed back surgery syndrome, spinal cord stimulation (SCS) using high-frequency programming (1,000 Hz) resulted in significant pain relief, with overall pain scores improving from 7.5 to 3.8 after 3 months (P < 0.01).

The majority of patients reported high satisfaction with the treatment, with 84% satisfied and 78.1% willing to recommend SCS, while adverse events were common but resolved without reoperation, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options: A Prospective, Open-Label Study of High-Dose Spinal Cord Stimulation in Patients with Chronic Back and Leg Pain. Benyamin, R., Galan, V., Hatheway, J., et al.[2020]

In a study of 24 patients with conditions like multiple sclerosis and spinal cord injury, chronic electrical stimulation of the spinal cord showed positive effects on motor performance in 14 patients who actively used the system, including improved bladder control and reduced spasticity.

Despite some technical issues and lack of noticeable effects in a few patients, the majority experienced benefits such as better movement coordination and increased endurance, suggesting that spinal cord stimulation can be an effective intervention for certain neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the effect of spinal cord stimulation on motor performance in patients with upper motor neuron lesions. Campos, RJ., Dimitrijevic, MM., Faganel, J., et al.[2019]

Citations

1. medtronic.com medtronic.com/en-us/healthcare-professionals/specialties/pain-management/therapies-procedures/spinal-cord-stimulation/clinical-evidence/publications.html

Publications - Spinal Cord Stimulation Therapy Access important publications about the efficacy of Medtronic spinal cord stimulation devices for chronic pain.

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P840001S469B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The safety and effectiveness of the Medtronic implantable neurostimulation system to treat PDN was based on clinical safety outcome data from the Medtronic ...

3. news.medtronic.com news.medtronic.com/New-12-month-clinical-data-highlights-significant-and-sustained-benefits-of-the-Inceptiv-TM-closed-loop-spinal-cord-stimulation-system

New 12-month clinical data highlights significant and ... Study shows 67% mean reduction in Low-back Visual Analog Scale (VAS) pain score at 12 months; 87% of subjects had meaningful improvements in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5157722/

Spinal Cord Stimulation (SCS)—The Implantable Systems ... Medtronic regularly releases updates of the product performance data in the form of the Medtronic Neuromodulation Product Performance Report.

5. medtronic.com medtronic.com/en-us/healthcare-professionals/specialties/pain-management/therapies-procedures/spinal-cord-stimulation/conditions.html

Conditions - Spinal Cord Stimulation Therapy SCS is indicated for intractable chronic neuropathic pain. See our data to understand how SCS therapy provides durable and sustainable relief from intractable ...

6. medtronic.com medtronic.com/en-us/l/isw/spinal-cord-stimulation-indications-safety-warnings.html

Spinal Cord Stimulation - Indications, Safety, and Warnings Avoid activities that put stress on the implanted neurostimulation system components. Recharging a rechargeable neurostimulator may result in skin irritation or ...

7. medtronic.com medtronic.com/in-en/patients/treatments-therapies/spinal-cord-stimulation-chronic-pain/important-safety-information.html

Spinal Cord Stimulation for Chronic Pain - Important Safety ... A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the management of chronic, intractable pain.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S357B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) Poor surgical candidates;. • Unable to operate the SCS system;. • Failed trial stimulation by failing to receive effective pain relief;. • Pregnant. IV.