Recruiting PHASE4 Proximal Junctional Kyphosis

New treatment option for Proximal Junctional Kyphosis

Official title Post-Operative Thoracolumosacral Orthosis for PJK

ClinicalTrials.gov ID: NCT06491030

What this study is testing

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 30 to 75

You may be able to join if

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

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Carmel, Indiana, United States
  • Overland Park, Kansas, United States
  • New York, New York, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Carmel, Indiana, United States; Overland Park, Kansas, United States; New York, New York, United States; Bellaire, Texas, United States; Dallas, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.