Not yet recruitingOBSERVATIONAL

A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis

This study is a look-back at the medical records of children and teenagers who have been treated for a condition called idiopathic scoliosis. This is when the spine develops a sideways curve for no clear reason. The study specifically investigated how well a particular treatment, called the REFLECT™ Scoliosis Correction System, worked for these young people. Researchers gathered information from their medical notes and X-rays from before their surgery and for at least a year afterwards to see the long-term results of the REFLECT™ system. By reviewing past cases, the study aims to understand the treatment's effectiveness in real-world situations.

At a glance

Status

Not yet recruiting

Sponsor

Globus Medical Inc

Enrolment target

100

Start

15 Jun 2026

Estimated completion

31 Jul 2027

Idiopathic Scoliosis

What is this study about?

This study is about a health problem called idiopathic scoliosis. This is when a child or teenager's spine (backbone) develops a sideways curve without a clear cause. Doctors often try different treatments, and sometimes surgery is needed to help straighten the spine.

This particular study looked back at the medical records of children and teenagers who had surgery using a specific medical device called the REFLECT™ Scoliosis Correction System. It's a bit like looking through old patient files to see how well a treatment worked. The doctors involved in the study gathered information from X-rays and medical notes taken before the surgery and for at least a year afterwards. They wanted to understand if this system helped to correct the spinal curve and what the outcomes were for these young patients.

Studies like this are important because they help doctors learn more about how different treatments work in real people. By reviewing past cases, they can get a better idea of how effective and safe a treatment like the REFLECT™ system is for idiopathic scoliosis. This information can then help doctors make better decisions about care for other children and teenagers with the same condition in the future.

Key takeaways

This study reviewed past medical records of children and teenagers.
It focused on idiopathic scoliosis, a sideways spinal curve.
The study examined the results of the REFLECT™ Scoliosis Correction System.
No new patients are being recruited for this study.
Information from existing patient records is used to learn about the treatment.
The aim is to help improve future care for scoliosis patients.

Who may be eligible?

This study looked at specific types of children and teenagers who had already received the REFLECT™ Scoliosis Correction System. They were included if their spine curve was between 30 and 65 degrees, and their bones were strong enough for the screws used in the surgery. They also had to be growing, rather than fully grown, and surgical treatment was necessary because other treatments like bracing hadn't worked or couldn't be tolerated.

There were also certain reasons why someone's records would not be included. For example, if they had an infection at the time of surgery, had already had spinal surgery before at the same part of the spine, or had very weak bones. Also, if there were other health problems, such as bleeding issues, allergies to parts of the implant, or if the patient couldn't follow care instructions after surgery, their records wouldn't be part of the review.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Did I have idiopathic scoliosis?
Was my spinal curve between 30 and 65 degrees?
Was I still growing (skeletally immature) when treated?
Did I have surgery using the REFLECT™ Scoliosis Correction System?
Was surgery needed because bracing didn't work or couldn't be used?
Do medical records exist from before surgery and at least 12 months after?

Answer every question to see your result.

What does participation involve?

Please note that this is a 'retrospective review' study. This means that researchers are looking back at existing medical records of patients who have already had treatment and completed their follow-up care. Therefore, no new patients will be recruited for this study, and there is no direct participation required from individuals at this stage. You don't need to visit a clinic, take any medication, or have assessments specifically for this study. The information from patients who have already been treated is being used to learn about the REFLECT™ system.

Potential risks and benefits

Since this study is a review of past medical records, there are no direct risks or benefits for individual patients. The study aims to gather information that could potentially benefit future patients by helping doctors understand the effectiveness of the REFLECT™ system. However, as with any medical procedure, the original surgery itself carried its own risks and benefits, which would have been discussed with patients and their families at the time. Patients always have the right to discuss their medical records and care with their doctors.

Locations (3)

NYU Langone Orthopedic Center
Verified postcode
New York, United States
Eifel Clinic St. Brigida GmbH & Co. KG
Verified postcode
Simmerath, Germany
Acibadem Maslak Hospital
Verified postcode
Istanbul, Turkey (Türkiye)

Common questions

What is idiopathic scoliosis?

It's a condition where the spine (backbone) curves sideways for no clear reason, usually in children or teenagers.

What is the REFLECT™ Scoliosis Correction System?

It's a specific type of surgical treatment used to help straighten the spine in children and teenagers with scoliosis.

Am I being asked to join this study?

No, this study is looking back at old patient records. No new patients are being recruited or asked to take part directly.

Are my medical records safe?

Yes, all medical information used in studies like this is handled confidentially and securely, following strict privacy rules.

How does this study help people?

By looking at past treatments, doctors can learn more about how well the REFLECT™ system works, which can help improve care for future patients.

How to find out more

Rebecca Smith

rsmith@globusmedical.com 858-922-7112 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.