Plain English Summary
Background and study aims
Although surgery is the only form of treatment that provides the lasting reduction of a deformed spine (idiopathic scoliosis), it does so at the expense of spinal motion. Also, fusion done early in the adolescent growth spurt may significantly limit growth. A new treatment that provides lasting control of the curve without these limitations would be a meaningful addition to the armamentarium of surgical treatments for AIS.
This research study involves the use of an investigational medical device, called SCOLITETHER(MIScoli) System (internal bracing). The system is being developed for the treatment of idiopathic scoliosis (scoliosis for which the cause is unknown), to reduce deformity and prevent its worsening in growing children/adolescents at high risk for curve progression while preserving motion. The SCOLIOTETHER system uses screws to attach to the spine’s bone growth on the curved side so that as your child grows the curve may stop progressing or improve. The SCOLITETHER system was used only in a group of five female subjects in a clinical pilot study conducted in Singapore and it was observed that the use of this system to address idiopathic thoracic scoliosis was effective and safe. It is not available for use by doctors because it is not yet approved for use. Health Canada has reviewed and approved the use of the SCOLITETHER system in this clinical trial.
Who can participate?
Children aged over 8 with idiopathic scoliosis who have at least three years of estimated growth remaining
What does the study involve?
The purpose of this clinical study is to demonstrate that the SCOLITETHER system is safe for use and shows probable benefit by stopping the progression of the major curve (Cobb angle) of a scoliosis in growing children and adolescents when compared to their initial curvature.
What are the possible benefits and risks of participating?
Any research study has potential risks. The medical device and the surgery may have risks and cause discomfort and inconveniences, some of which may be unknown at this time. The SCOLITETHER system might potentially avoid the need for fusion surgery resulting in a greater range of motion and more flexibility. Fusion surgery usually involves an open back incision compared to the small incisions with the SCOLITETHER system surgery. This leads to a much shorter recovery time. There may be less risk of infection, less blood loss, and so less need for blood transfusion, increase range of motion and less pain with the SCOLITETHER system.
When is the study starting and how long is it expected to run for?
March 2019 to March 2020.
Where is the study run from?
The study is being held in 4 different locations throughout Canada.
1. Sainte-Justine Hospital in Montreal, Quebec
2. The Montreal Children’s Hospital in Montreal, Quebec
3. The Children’s Hospital of Eastern Ontario in Ottawa, Ontario
4. British Columbia’s Children’s Hospital in Vancouver, BC
5. IWK Health in Nova Scotia
Who is the main contact?
Dr Firoz Miyanji, 604.875.2000
Trial website
Contact information
Type
Scientific
Primary contact
Dr Firoz Miyanji
ORCID ID
http://orcid.org/0000-0002-3023-3660
Contact details
BC Children's Hospital
4480 Oak Street
Vancouver
V6H 3V4
Canada
604-875-2000
fmiyanji@cw.bc.ca
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CD-0001-PRO/FUTURE
Study information
Scientific title
Fusionless Treatment of Idiopathic Scoliosis with the Scoli-Tether System for the treatment of juvenile and adolescent idiopathic scoliosis (AIS)
Acronym
FUTURE
Study hypothesis
The SCOLI-TETHER system shows benefit to halt the progression of the major curve of scoliosis reflected by a decrease in the Cobb angle compared to baseline.
Ethics approval
Site 01 – Approved 06/05/2019, Le CHU Sainte-Justine (3175, Chemin de la Côte-Sainte-Catherine, Montreal, Quebec, Canada, H3T 1C5)
Site 02 – Approved 20/06/2019, The Montreal Children’s Hospital (1001 Boulevard Décarie, Montreal, Quebec, Canada, H4A 3J1)
Site 03 – Approved 19/02/2019, The Children’s Hospital of Eastern Ontario Research Ethics Board (401 Smyth Road, Room R2110, CHEO Research Institute Building 2, Ottawa, Ontario, K1H 8L1; 613-737-7600 ext.3350; nanderson@cheo.on.ca), ref: 18/17E
Site 04 – Approved 23/01/2019, British Columbia’s Children’s Hospital (4480 Oak Street, Vancouver, British-Columbia, Canada, V6H 3V4), ref: UBC C&W NUMBER:H18-02322
Site 05 – Approved 27/02/2020, IWK Health (5850 University Avenue, PO Box 9700, Halifax, Nova Scotia, Canada, B3K 6R8)
Study design
Multicentre single-arm interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Major thoracic scoliosis with Cobb Angle greater than 40° and Lenke I, II and V curve pattern.
Intervention
Current interventions as of 06/03/2020:
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. This device is intended for use in patients greater than 8 years of age with significant growth remaining who have a major thoracic scoliosis with Cobb Angle greater than 40° and Lenke I, II and V curve pattern. Patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure. It is intended to be used at contiguous levels through an anterior thoracoscopic or open technique between T4 and L2 inclusively. The device is intended to treat major thoracic scoliosis in patients who have less than 50° of thoracic kyphosis (T5-T12) and a Risser stage of 0 or 1.
Previous interventions:
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. This device is intended for use in patients 8-13 years of age who have a major thoracic scoliosis with Cobb Angle greater than 40° and Lenke I, II and V curve pattern. It is intended to be used at contiguous levels through an anterior thoracoscopic or open technique between T4 and L2 inclusively. The device is intended to treat major thoracic scoliosis in patients who have less than 50° of thoracic kyphosis (T5-T12) and a Risser stage of 0 or 1.
X-rays will be taken to monitor the progress from baseline to 5-year follow-up. The x-ray will take place at the participant’s local participating hospital and reviewed by an independent laboratory different from the hospital.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Benefit of SCOLI-TETHER System in halting the progression of the major curve (Cobb angle) of scoliosis in growing subject measured by examination of x-rays at baseline and 5-year follow-up. The x-rays will be reviewed by an independent contract laboratory organization
Secondary outcome measures
Quality of life of the subjects that were treated with the SCOLI-TETHER System measured using SRS-30 questionnaire at 5 year follow-up.
Overall trial start date
01/06/2017
Overall trial end date
01/08/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 06/03/2020:
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
Previous inclusion criteria:
1. Diagnosis of juvenile or adolescent idiopathic scoliosis
2. Greater than or equal to 8 and less or equal than 13 years of age
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
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
41
Participant exclusion criteria
Current exclusion criteria as of 06/03/2020:
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
Previous exclusion criteria:
1. The vertebrae to be instrumented is less than 12 mm in height (based on the staple size)
2. One of the vertebrae to be instrumented in less than 22 mm in width (base on smallest screw length)
3. One of the vertebrae to be instrumented in more than 44 mm in width (base on longest screw length)
4. Non-idiopathic scoliosis
5. Non-ambulatory
6. Clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget’s disease and metabolic bone disease
7. Prior thoracic surgery
8. Abnormal neurological status at baseline
9. 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
Recruitment start date
01/04/2019
Recruitment end date
31/03/2020
Locations
Countries of recruitment
Canada
Trial participating centre
CHU Sainte-Justine Hospital
3175 Chemin de la Cote-Sainte-Catherine
Montreal
H3T1C5
Canada
Trial participating centre
The Montreal Children's Hospital
1001 Boulevard Decarie
Montreal
H4A3J1
Canada
Trial participating centre
The Children's Hospital of Eastern Ontario
401 Smyth Road
Ottawa
K1H8L1
Canada
Trial participating centre
British Columbia's Children's Hospital
4480 Oak Street
Vancouver
V6H 3V4
Canada
Trial participating centre
IWK Health
5850 University Avenue
PO Box 9700
Halifax
B3K 6R8
Canada
Sponsor information
Organisation
Spino Modulations Inc
Sponsor details
6750 avenue de L'Esplanade
Montreal
H2V 1A2
Canada
1-888-988-2747
regulatory@spinologics.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Spino Modulation Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of the trial will be submitted to the Scoliosis Research Society annual meeting and a publication will be submitted to Spine.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
01/08/2025
Participant level data
Other
Basic results (scientific)
Publication list