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NCT06491030RECRUITINGIRB Ready

Post-Operative Thoracolumosacral Orthosis for PJK

Sponsored by Hospital for Special Surgery, New York

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 84 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown.

Who Can Participate

Inclusion Criteria

30-75-years-old
Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumented vertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or the ilium.

Exclusion Criteria

Osteoporosis (defined as a T-score \<-2.5 at the time of surgery)
Body mass index (BMI) \>35 kg/m2
Revision fusions
Fusions for trauma
Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)
An underlying inflammatory arthropathy

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

84 participants

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Age Range

30 Years - 75 Years

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Gender

ALL

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Sponsor

Hospital for Special Surgery, New York

Study Locations

Choose your preferred location or select flexible during enrollment

ACTIVE_NOT_RECRUITING

Carmel

Indiana

Location available
View Carmel location page
ACTIVE_NOT_RECRUITING

Overland Park

Kansas

Location available
View Overland Park location page
RECRUITING

New York

New York

Location available
View New York location page
ACTIVE_NOT_RECRUITING

Bellaire

Texas

Location available
View Bellaire location page
ACTIVE_NOT_RECRUITING

Dallas

Texas

Location available
View Dallas location page
ACTIVE_NOT_RECRUITING

Seattle

Washington

Location available
View Seattle location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

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

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Spinal deformity Treatment in Carmel?

Join others in Indiana exploring innovative treatment options through clinical research

Spinal deformity Treatment Options in Carmel, Indiana

If you're searching for Spinal deformity treatment in Carmel, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Carmel, Overland Park, New York and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Spinal deformity. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Indiana
Now Enrolling
Up to 84 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Spinal deformity?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Spinal deformity

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Spinal deformity Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06491030. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.