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

NCT ID: NCT04992845

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2023-09-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Vertebral Body Tethering surgery

Group Type: EXPERIMENTAL

Anterior Vertebral Body Tethering

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spino Modulation Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Firoz Miyanji

Role: PRINCIPAL_INVESTIGATOR

BC Children's

Kevin Smit

Role: PRINCIPAL_INVESTIGATOR

CHEO

Locations

CHEO

Ottawa, , Canada

Countries

Canada

Other Identifiers

CD-0001-PRO

Identifier Type: -

Identifier Source: org_study_id