REFLECT Scoliosis System Post Approval Study

A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System

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

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Device: REFLECT Scoliosis Correction System

Detailed Description

The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials. REFLECT™ uses a growth modulation technique in which growth of the patient is used to achieve progressive scoliosis correction.

The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.

A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 U.S. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. Primary and secondary outcomes from 100 patients enrolled and treated with REFLECT™ will be summarized.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline Myer, BS; Phone Number: 1669 610-930-1800; Email: jmyer@globusmedical.com

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
      • Principal Investigator: Noelle Larson, MD
      • Contact: Jana Robinson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: REFLECT; Enrolled patients are treated with the REFLECT Scoliosis System. This is an HDE-approved device.	Device: REFLECT Scoliosis Correction System; The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Probable Benefit	Maintenance of major Cobb angle less than or equal to 40°	60 months postoperative
Primary Safety	Serious adverse events (SAEs) and device- or procedure-related adverse events (AEs)	60 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Curve progression	Curve progression no greater than 10° of any secondary curve above or below the implant, or development of a new curve equal to or greater than 40°	60 months postoperative
Device integrity	Device integrity failures including cord breakage and screw migration	60 months postoperative
Composite endpoint analysis	Maintenance of major Cobb angle less than or equal to 40° AND freedom from Serious Adverse Events (SAEs) during the procedure and procedure/device related SAEs following surgery	60 months postoperative
Failure analysis	Analysis of the failure attributable to conversion to another spinal implant OR major Cobb angle that exceeded 40° at defined follow-up visit OR any progression of the major curve at defined follow-up compared to baseline OR death OR permanent disability	60 months postoperative
SRS score	Mean score of Scoliosis Research Society 22r Patient Questionnaire	60 months postoperative

Collaborators and Investigators

• Sponsor: Globus Medical Inc

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2032

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: Protocol Rev 0 11July2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No