Saint Paul, MNNCT04914507Now EnrollingIRB Ready

Scoliosis Idiopathic Clinical Trial in Saint Paul, MN

Access cutting-edge scoliosis idiopathic treatment through this clinical trial at a research site in Saint Paul. Study-provided care at no cost to qualified participants.

Sponsored by Pediatric Spine Foundation

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Expert Care in Saint Paul

Access scoliosis idiopathic specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related scoliosis idiopathic treatment provided free

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Check if you qualify for this scoliosis idiopathic clinical trial in Saint Paul, MN

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Saint Paul

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Saint Paul site if eligible
  4. 4Begin participation

About This Scoliosis Idiopathic Study in Saint Paul

Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device

Sponsor: Pediatric Spine Foundation

Who Can Participate

Inclusion Criteria

Skeletally immature patients that receive AVBT surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Specifically:
Diagnosis of idiopathic scoliosis
Planned recipient of AVBT surgical treatment
Skeletally immature
Major Cobb angle ≥30° and ≤65°
Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
Failed or intolerant to bracing

Exclusion Criteria

Presence of any systemic infection, local infection, or skin compromise at the anticipated surgical site
Prior spinal surgery at the level(s) to be treated
Evidence of documented poor bone quality
Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions as determined by the treating physician
Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
Unwillingness to sign Informed Consent Form and participate in study procedures

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Saint Paul?

Yes, this clinical trial (NCT04914507) has an active research site in Saint Paul, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Scoliosis Idiopathic Treatment Options in Saint Paul, MN

If you're searching for scoliosis idiopathic treatment options in Saint Paul, MN, this clinical trial (NCT04914507) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Saint Paul research site is actively enrolling participants for this clinical trial. You'll receive care from experienced scoliosis idiopathic specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all scoliosis idiopathic clinical trials near you to find additional studies recruiting in your area.

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