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

Adolescent Idiopathic Scoliosis Clinical Trial

— FUTURE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04992845
• Other study ID #: CD-0001-PRO
• Status: Terminated
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2023
• Source: Spinologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
Canada	CHEO	Ottawa

Sponsors (1)

Lead Sponsor	Collaborator
Spino Modulation Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Cobb angle measurement	The change in Cobb angle measurement from baseline (preoperative) to 12 months	12 months