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

NCT04992845 | Terminated DMC

• 1 other identifier: CD-0001-PRO
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescent Idiopathic Scoliosis; Juvenile Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

Vertebral Body Tethering surgery

Device: Anterior Vertebral Body Tethering

Interventions

Anterior Vertebral Body Tethering DEVICE

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.

Intervention

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of juvenile or adolescent idiopathic scoliosis
• Male and female subjects greater than 8 years of age with significant growth remaining
• Risser Stage 0 or 1
• Subjects should have at least three years of estimated growth remaining based on Risser staging
• 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
• Thoracic kyphosis (T5-T12) \< 50°
• Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive)
• Menses \< 4 months
• Subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations
• Subject assent and parent/legal guardian consent obtained and documented.

You may not qualify if:

• Scoliosis curve is less than 30° or more than 70°
• Thoracic kyphosis is greater than or equal to 50° (T5-T12)
• The vertebrae to be instrumented is less than 12mm in height (based on the staple size)
• One of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length)
• One of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length)
• Non-idiopathic scoliosis
• Non-ambulatory
• Subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget's disease and metabolic bone disease
• Prior thoracic surgery
• Abnormal neurological status at baseline
• 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

Sponsors & Collaborators

• Spino Modulation Inc.: lead

Study Sites (1)

CHEO

Ottawa, Canada

Location

Study Officials

• Firoz Miyanji

  BC Children's

  PRINCIPAL INVESTIGATOR

• Kevin Smit

  CHEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 5, 2021
• Study Start: April 15, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 15, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)