Adolescent Idiopathic ScoliosisFUTURENCT04992845
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
A study testing Anterior Vertebral Body Tethering in people with Adolescent Idiopathic Scoliosis and Juvenile Idiopathic Scoliosis, run by Spino Modulation Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis
- What is being tested?
- Anterior Vertebral Body Tethering
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2019to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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°
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Anterior Vertebral Body Tethering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Vertebral Body TetheringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Vertebral Body Tethering surgery Receives: Device: Anterior Vertebral Body Tethering |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Change in Cobb angle measurement
The change in Cobb angle measurement from baseline (preoperative) to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start15 Apr 2019
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: The Sponsor decided to focus their resources on the clinical data collection for the second generation of the investigational device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spino Modulation Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Firoz Miyanji, Principal investigator, BC Children'sKevin Smit, Principal investigator, CHEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992845
- Sponsor's protocol ID
- CD-0001-PRO
- Acronym
- FUTURE
- Status last verified
- Apr 2023
- First submitted
- 23 Jul 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
- ClinicalTrials.gov ID
- NCT04992845
- Acronym / sponsor ID
- FUTURE / CD-0001-PRO
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor decided to focus their resources on the clinical data collection for the second generation of the investigational device.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Spino Modulation Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Anterior Vertebral Body TetheringVertebral Body Tethering surgery |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Vertebral Body TetheringThe 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. | Device | Intervention |
Primary outcome
Rate of device- &/or procedure-related SAEs
Time frame: 12 months
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
Time frame: 12 months
The change in Cobb angle measurement from baseline (preoperative) to 12 months
Results and safety
The study was stopped early (reason given: The Sponsor decided to focus their resources on the clinical data collection for the second generation of the investigational device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firoz Miyanji principal investigator
BC Children's
Kevin Smit principal investigator
CHEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Vertebral Body Tethering in people with Adolescent Idiopathic Scoliosis and Juvenile Idiopathic Scoliosis, run by Spino Modulation Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Sponsor decided to focus their resources on the clinical data collection for the second generation of the investigational device.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device- &/or procedure-related SAEs (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.