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

Primary Purpose

Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anterior Vertebral Body Tethering
Sponsored by
Spino Modulation Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHEO

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Vertebral Body Tethering surgery

Outcomes

Primary Outcome Measures

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
Change in Cobb angle measurement
The change in Cobb angle measurement from baseline (preoperative) to 12 months

Secondary Outcome Measures

Full Information

First Posted
July 23, 2021
Last Updated
April 26, 2023
Sponsor
Spino Modulation Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04992845
Brief Title
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
Acronym
FUTURE
Official Title
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spino Modulation Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Vertebral Body Tethering surgery
Intervention Type
Device
Intervention Name(s)
Anterior Vertebral Body Tethering
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of device- &/or procedure-related SAEs
Description
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
Time Frame
12 months
Title
Change in Cobb angle measurement
Description
The change in Cobb angle measurement from baseline (preoperative) to 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firoz Miyanji
Organizational Affiliation
BC Children's
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Smit
Organizational Affiliation
CHEO
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHEO
City
Ottawa
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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