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

Not Applicable

Terminated

• Conditions: Juvenile Idiopathic Scoliosis; Adolescent Idiopathic Scoliosis
• Interventions: Device: Anterior Vertebral Body Tethering

• Registration Number: NCT04992845
• Lead Sponsor: Spino Modulation Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-05
• Status Verified: 2023-04
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Anterior Vertebral Body Tethering	Vertebral Body Tethering surgery

Primary Outcome Measures

Name	Time	Method
Change in Cobb angle measurement	12 months	The change in Cobb angle measurement from baseline (preoperative) to 12 months
Rate of device- &/or procedure-related SAEs	12 months	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

Trial Locations

Locations (1)

CHEO; 🇨🇦 Ottawa, Canada