Fusionless treatment of idiopathic scoliosis with the MIScoli™ system during the growth period (FUTURE)
| ISRCTN | ISRCTN10892409 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10892409 |
| Secondary identifying numbers | CD-0001-PRO/FUTURE |
- Submission date
- 12/03/2019
- Registration date
- 18/03/2019
- Last edited
- 15/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Current plain English summary as of 27/10/2021:
Background and study aims
Although fusion 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 Adolescent Idiopathic Scoliosis (AIS).
This research study involves the use of an investigational medical device, called 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 MIScoli™ 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 MIScoli™ 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 MIScoli™ 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 MIScoli™ 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 MIScoli™ 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 MIScoli™ 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 MIScoli™ system.
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
When is the study starting and how long is it expected to run for?
June 2017 to September 2023
Who is funding the study?
Spino Modulation Inc (Canada)
Who is the main contact?
Dr Firoz Miyanji, fmiyanji@cw.bc.ca
Dr Kevin Smit, KSmit@cheo.on.ca
_____
Previous 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?
June 2017 to August 2025
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, fmiyanji@cw.bc.ca
Dr Kevin Smit, KSmit@cheo.on.ca
Contact information
Scientific
The Children's Hospital of Eastern Ontario
401 Smyth Road
Ottowa
K1H 8L1
Canada
| Phone | +1 613-737-7600 |
|---|---|
| KSmit@cheo.on.ca |
Scientific
BC Children's Hospital
4480 Oak Street
Vancouver
V6H 3V4
Canada
 ORCID ID |
0000-0002-3023-3660 |
|---|---|
| Phone | +1 604-875-2000 |
| fmiyanji@cw.bc.ca |
Study information
| Study design | Multicentre single-arm interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Fusionless treatment of idiopathic scoliosis with the MIScoli™ system during the growth period (FUTURE) |
| Study acronym | FUTURE |
| Study objectives | Current Study Hypothesis as of 27/10/2021: The MIScoli™ system shows benefit to halt the progression of the major curve of scoliosis reflected by a decrease in the Cobb angle from Visit 1 / Pre-Op baseline to Visit 6 / 1 Year. _____ Previous 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(s) | Current ethics approval as of 25/01/2021: 1. Approved 21/07/2020, Le CHU Sainte-Justine (3175, Chemin de la Côte-Sainte-Catherine, Montreal, Quebec, Canada, H3T 1C5) 2. Approved 06/05/2019, The Montreal Children’s Hospital (1001 Boulevard Décarie, Montreal, Quebec, Canada, H4A 3J1) 3. Approved 21/07/2020, 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 4. Approved 26/06/2020, British Columbia’s Children’s Hospital (4480 Oak Street, Vancouver, British-Columbia, Canada, V6H 3V4), ref: UBC C&W NUMBER:H18-02322 5. Approved 15/07/2020, IWK Health (5850 University Avenue, PO Box 9700, Halifax, Nova Scotia, Canada, B3K 6R8) _____ Previous 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) |
| Health condition(s) or problem(s) studied | Current condition as of 27/10/2021: Major thoracic scoliosis with Cobb Angle greater than 40° and less than 70° and Lenke I, II or V curve pattern. Children/adolescents with curves greater than 30° with attempted but failed brace treatment are also potential candidates for this study. _____ Previous Condition: Major thoracic scoliosis with Cobb Angle greater than 40° and Lenke I, II and V curve pattern. |
| Intervention | Current interventions as of 27/10/2021: The 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 and less than 70°, 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 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MIScoli™ |
| Primary outcome measure | Current primary outcome measure as of 27/10/2021: Benefit of MIScoli™ 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 3-year follow-up. The x-rays will be reviewed by an independent contract laboratory organization. _____ Previous primary outcome measure as of 25/01/2021: 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 3-year follow-up. The x-rays will be reviewed by an independent contract laboratory organization. _____ Previous 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 | Current secondary outcome measures as of 27/10/2021: Quality of life of the subjects that were treated with the MIScoli™ system measured using SRS-30 questionnaire at 3 year follow-up. _____ Previous secondary outcome measures as of 25/01/2021: Quality of life of the subjects that were treated with the SCOLI-TETHER System measured using SRS-30 questionnaire at 3 year follow-up _____ Previous 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 study start date | 01/06/2017 |
| Completion date | 01/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 59 |
| Key inclusion criteria | Current inclusion criteria as of 27/10/2021: 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 at Visit 1. 4. Subjects should have at least three years of estimated growth remaining based on European Risser staging. 5. Major thoracic scoliosis with Cobb angle > 40° and < 70° and Lenke I, II or V curve pattern. Cobb angle measurements refer to measures taken without a brace. Subjects with curves greater than 30° with attempted but failed brace treatment are also potential candidates for this study. 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 at Visit 1 9. Subject must be physically and mentally willing and able to comply with the study visit schedule and all protocol requirements. 10. Subject assent and parent/legal guardian consent obtained and documented. _____ Previous 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 |
| Key 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 |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 02/02/2022 |
Locations
Countries of recruitment
- Canada
Study participating centres
Montreal
H3T1C5
Canada
Montreal
H4A3J1
Canada
Ottawa
K1H8L1
Canada
Vancouver
V6H 3V4
Canada
PO Box 9700
Halifax
B3K 6R8
Canada
Sponsor information
Industry
4200 boul. St-Laurent suite #1100
Montreal
QC H2W 2R2
Canada
| Phone | +1-888-988-2747 |
|---|---|
| regulatory@spinologics.com | |
| Website | https://www.spinologics.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
15/11/2023: The overall study end date was changed from 01/08/2025 to 01/09/2023.
03/02/2022: The recruitment end date was changed from 30/06/2022 to 02/02/2022.
The following changes were made to the trial record:
1. The public title was changed from "Treatment of early adolescent spinal deformity with the Scoli-Tether System" to "Fusionless treatment of idiopathic scoliosis with the MIScoli™ system during the growth period (FUTURE)".
2. The plain English summary was changed.
3. The scientific title was changed from "Fusionless Treatment of Idiopathic Scoliosis with the Scoli-Tether System for the treatment of juvenile and adolescent idiopathic scoliosis (AIS)" to "Fusionless treatment of idiopathic scoliosis with the MIScoli™ system during the growth period (FUTURE)".
4. The condition was changed.
5. The primary outcome measure was changed.
6. The secondary outcome measures were changed.
7. The inclusion criteria were changed.
8. The target number of participants was changed from 51 to 59.
9. The recruitment end date was changed from 30/06/2021 to 30/06/2022.
10. The sponsor details were updated.
25/01/2021: The following changes were made to the trial record:
1. A contact was added.
2. The ethics details were changed.
3. The primary outcome measure was changed.
4. The secondary outcome measures were changed.
5. The target number of participants was changed from 41 to 51.
6. The recruitment end date was changed from 31/03/2020 to 30/06/2021.
7. The plain English summary was updated to reflect these changes.
06/03/2020: Ethics approval, interventions, inclusion and exclusion criteria were updated.
04/12/2019: Added ethics approval details and trial participating centre IWK Health.
28/08/2019: The ethics approval was updated.
15/03/2019: Trial’s existence confirmed by IRB.
