BridgeMD
New treatment option for Idiopathic Scoliosis
Official title REFLECT Scoliosis System Post Approval Study
ClinicalTrials.gov ID: NCT06298812
What this study is testing
- What it's testing
- The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Diagnosis of progressive idiopathic scoliosis
- Preoperative major Cobb angle 30°-65°
- Preoperative flexibility to ≤30° on side bending radiograph (left or right)
- Skeletally immature at the time of surgery with Risser sign \<5 or Sanders score \<8
- Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
You likely can't join if
- Prior spinal surgery at the level(s) to be treated
- Documented poor bone quality, defined as a T-score of -1.5 or less
- Presence of any systemic infection, local infection, or skin compromise at the surgical site
- Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the...
- Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study...
- Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present...
See the full eligibility criteria
- Diagnosis of progressive idiopathic scoliosis
- Preoperative major Cobb angle 30°-65°
- Preoperative flexibility to ≤30° on side bending radiograph (left or right)
- Skeletally immature at the time of surgery with Risser sign \<5 or Sanders score \<8
- Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
- Failed or intolerant to bracing
- Signed informed consent and/or assent forms specific to this study
- Prior spinal surgery at the level(s) to be treated
- Documented poor bone quality, defined as a T-score of -1.5 or less
- Presence of any systemic infection, local infection, or skin compromise at the surgical site
- Any 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...
- 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...
- Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- New York, New York, 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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; New York, New York, 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.