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Device

Medtronic Device Follow-Up for Spinal Conditions

N/A
Recruiting
Research Sponsored by Medtronic Spinal and Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months and up to 24 months
Awards & highlights

Study Summary

This trial collects performance and safety data from people who already have Medtronic devices used for cranial and/or spinal conditions, monitored over 24 months.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves post-market medical devices rather than drugs, specific side effects are not listed; however, typical risks may include infection at the surgery site, pain, swelling or complications related to spine surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months and up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used)
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
+2 more
Secondary outcome measures
Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]
Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Other Spinal Hardware, Rods and Screws]

Trial Design

3Treatment groups
Experimental Treatment
Group I: Receiving eligible device(s) from all other product groupsExperimental Treatment1 Intervention
Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)
Group II: Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)Experimental Treatment1 Intervention
Group III: Receiving eligible Advanced Energy device(s)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Medtronic Spinal and BiologicsLead Sponsor
55 Previous Clinical Trials
9,588 Total Patients Enrolled
2 Trials studying Scoliosis
178 Patients Enrolled for Scoliosis
Medtronic Bakken Research CenterIndustry Sponsor
97 Previous Clinical Trials
76,519 Total Patients Enrolled

Media Library

Medtronic devices (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05856370 — N/A
Scoliosis Research Study Groups: Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s), Receiving eligible Advanced Energy device(s), Receiving eligible device(s) from all other product groups
Scoliosis Clinical Trial 2023: Medtronic devices Highlights & Side Effects. Trial Name: NCT05856370 — N/A
Medtronic devices (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05856370 — N/A
Scoliosis Patient Testimony for trial: Trial Name: NCT05856370 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being recruited for this experiment?

"Affirmative. According to clinicaltrials.gov, this trial has commenced recruitment of participants since its initial posting on May 1st 2023 and was last updated on the 9th of May 2023. Approximately 1000 patients are required across a single medical location."

Answered by AI

Is it possible for prospective participants to join the experiment at this time?

"Clinicaltrials.gov indicates that this research is still actively recruiting participants, with a trial start date of May 1st 2023 and most recent update on the 9th of May 2023."

Answered by AI

Who else is applying?

What site did they apply to?
The Ohio State University Wexner Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Am I eligible to get this Medtronic device treatment?
PatientReceived no prior treatments

Why did patients apply to this trial?

Losing feeling below my knees currently due to my spinal fusion failing and spine degenerating.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
The Ailliance Post-Market Clinical Study
2023. "The Ailliance Post-Market Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856370.
All > Scoliosis
~657 spots leftby Apr 2026
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