Condition category
Musculoskeletal Diseases
Date applied
12/03/2019
Date assigned
18/03/2019
Last edited
18/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and Study Aim:
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 from the age of 8 years old to 13 years old with idiopathic scoliosis who still has some more growing

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

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 – Le CHU Sainte-Justine (3175, Chemin de la Côte-Sainte-Catherine, Montreal, Quebec, Canada, H3T 1C5)– under review
Site 02 – The Montreal Children’s Hospital (1001 Boulevard Décarie, Montreal, Quebec, Canada, H4A 3J1) – under review
Site 03 – The Children’s Hospital of Eastern Ontario - approved 19/02/2019, CHEO 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 – British Columbia’s Children’s Hospital (4480 Oak Street, Vancouver, British-Columbia, Canada, V6H 3V4) – under review

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

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 hosptial

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

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

1. The vertebrae to be instrumented is less than 12mm in height (based on the staple size)
2. One of the vertebrae to be instrumented in less than 22mm in width (base on smallest screw length)
3. One of the vertebrae to be instrumented in more than 44mm 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

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

www.spinologics.com

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

Publication citations

Additional files

Editorial Notes

15/03/2019: Trial’s existence confirmed by IRB