Treatment for Scoliosis

The Ohio State University Wexner Medical Center, Columbus, OH
Scoliosis+4 More Conditions
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Scoliosis
  • Spinal Degeneration
  • Spinal Fusion Failure
  • Spinal Trauma
  • Spinal Tumor

Treatment Effectiveness

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: 12 months and up to 24 months

12 months
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
Month 24
Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used)
Index Surgery
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)
Up to 12 months
Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Other Spinal Hardware, Rods and Screws]
Up to 24 months
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

0 Treatment Group

1000 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months and up to 24 months

Who is running the clinical trial?

Medtronic Bakken Research CenterIndustry Sponsor
97 Previous Clinical Trials
76,574 Total Patients Enrolled
Medtronic Spinal and BiologicsLead Sponsor
55 Previous Clinical Trials
9,597 Total Patients Enrolled
2 Trials studying Scoliosis
178 Patients Enrolled for Scoliosis

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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