Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period (FUTURE)

The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.

Study Overview

• Status: Terminated
• Conditions: Adolescent Idiopathic Scoliosis; Juvenile Idiopathic Scoliosis
• Intervention / Treatment: Device: Anterior Vertebral Body Tethering

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ottawa, Canada
    • CHEO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Diagnosis of juvenile or adolescent idiopathic scoliosis
2. Male and female subjects greater than 8 years of age with significant growth remaining
3. Risser Stage 0 or 1
4. Subjects should have at least three years of estimated growth remaining based on Risser staging
5. Major thoracic scoliosis with Cobb Angle > 40° and < 70° and Lenke I, II or V curve pattern. Cobb measurements refer to measures taken without a brace. Patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure
6. Thoracic kyphosis (T5-T12) < 50°
7. Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive)
8. Menses < 4 months
9. Subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations
10. Subject assent and parent/legal guardian consent obtained and documented.

Exclusion Criteria:

1. Scoliosis curve is less than 30° or more than 70°
2. Thoracic kyphosis is greater than or equal to 50° (T5-T12)
3. The vertebrae to be instrumented is less than 12mm in height (based on the staple size)
4. One of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length)
5. One of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length)
6. Non-idiopathic scoliosis
7. Non-ambulatory
8. Subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget's disease and metabolic bone disease
9. Prior thoracic surgery
10. Abnormal neurological status at baseline
11. Any condition or therapy that the investigator believes might pose a risk to the participant or make participation in the study not in the participant's best interest

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
Experimental: Intervention; Vertebral Body Tethering surgery	Device: Anterior Vertebral Body Tethering; The SCOLI-TETHER (MIScoli) System is intended for anterolateral vertebral body fixation and internal fastening of the convex side of the thoracic curvatures thereby reducing the deformity and preventing the progression of idiopathic scoliosis in growing children/adolescents at high risk for curve progression while preserving motion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device- &/or procedure-related SAEs	Rate of positively adjudicated device or procedure related serious adverse events including subsequent secondary surgical intervention and neurological events from baseline (preoperative) through 12 months	12 months
Change in Cobb angle measurement	The change in Cobb angle measurement from baseline (preoperative) to 12 months	12 months

Collaborators and Investigators

• Sponsor: Spino Modulation Inc.
• Investigators: Principal Investigator: Firoz Miyanji, BC Children's; Principal Investigator: Kevin Smit, CHEO

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: CD-0001-PRO

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: No