No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Globus Medical Inc · Industry
Who this trial is looking for
This trial is looking for patients with idiopathic scoliosis who need treatment. Participants will be treated with the REFLECT™ Scoliosis Correction System and will be monitored for their outcomes.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with progressive idiopathic scoliosis
My major Cobb angle is between 30° and 65°
My spine can bend to a maximum of 30°
I am skeletally immature and have a Risser sign less than 5
I cannot wear a brace successfully
I can provide signed consent for this study
You may not be able to join if
I have had spinal surgery at the levels to be treated
My bone quality is poor as defined by a T-score of -1.5 or less
I have a current infection or wound at the surgery site
I have a medical condition that would make surgery unsafe
I cannot return for follow-up visits as required by the study
I am currently in another high-risk drug or device study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion 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 dimens…
Inclusion 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
Exclusion Criteria:
* 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 with post-operative care instructions
* 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
* 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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.