Adolescent Idiopathic ScoliosisNEMOST-AISNCT04441411
Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients
A study testing NEMOST system in people with Adolescent Idiopathic Scoliosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- NEMOST system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2020to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent idiopathic scoliosis ;
- Primary Cobb angle greater than 30°;
- Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time;
- Skeletally immature (Risser grade* ≤2 and Skeletal age of hand and wrist X-rays ≤14y);
- In girl, either pre-menarchal or post-menarchal by no more than 1 year;
- Age over 10 years;
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- Non rigid curve;
- All Lenke type;
- No previous spine surgery.
Who cannot join
- Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis);
- History of previous spine surgery;
- Risser sign >2;
- Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality);
- Non-reductible scoliosis;
- Known allergy or intolerance to one of the device material;
Show all 9Show fewer
- Acute or chronic infections, local or systemic;
- Absence or insufficience of covering tissues;
- Pathological obesity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
AmsterdamUMC, location AMC
Amsterdam, North Holland, 1105AZ
Dept of Orthopedics, +31(20)5662672
Dept of orthopaedics, +31(20)5662672
About this study
Official title: Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients Using the Nemost-AIS System
The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.
Read the detailed description
Scoliosis is a complex three-dimensional deformity of the spine, which occurs primarily in growing children and adolescents. In adolescent idiopathic scoliosis (AIS), the cause is unknown. Children with severe and progressive scoliosis, if left untreated, are at risk of rapid and severe spinal deformity progression, which can result in a decrease of pulmonary function, poor cosmetic result and poor quality of life.
Treatment options in AIS depend on curve severity and remaining growth potential, and include intensive brace treatment for smaller curvatures whereas surgical correction and spinal fusion is advocated for more severe curves. Growing rods are used for severe early infantile deformities or early onset scoliosis (EOS).
Bracing, by using a rigid plastic orthosis, is currently the primary therapy to prevent curve progression in mild curves up to 45 degrees and skeletal immature patients. Most braces are recommended to be worn for 18-23 hours per day during several years (until skeletal maturity has been reached). This may cause a high level of physical discomfort and emotional and psychological stress in these patients, and failure of brace treatment therefore is common.
Surgical therapy for AIS is recommended in severe progressive curvatures. Surgical treatment includes correction of the spinal curvature by using multisegmental screw fixation and posterior spinal fusion of the thoracolumbar spine. Complete posterior spinal fusion, however, lacks the possibilities for future adaptation of natural changes in spinal balance and posture.
Currently, growing rods systems are used as a posterior spinal implant to allow growth of the spine and thorax and limit progression of the scoliosis in young patients with early onset scoliosis. Growing rods systems are distractible spinal implants, with bipolar anchorage fixations to the upper and lower part of the spine, using posterior spinal instrumentation such as hooks and pedicle screws.
The Nemost growing system, developed by the EUROS Compagny, is a CE-marked commercial available medical device for the treatment of early onset neuromuscular or early onset idiopathic scoliosis. It is a non-fusion, growth enabling system with bipolar fixation intended to be used with a posterior spinal instrumentation.
It is hypothesized that the use of a minimal invasive non-fusion bipolar posterior spinal implant (Nemost growing domino) can both correct and brace the spine internally and adapt balans and or distraction as the idiopathic scoliosis patient grows.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- NEMOST system
- Keywords
- scoliosis, nonfusion, surgery, fusionless, idiopathic, adolescent
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEMOST systemDevice
Minimal invasive double rod posterior Non-Fusion Scoliosis Surgery
| Study group | Role | What they receive |
|---|---|---|
| NEMOST-AIS | Other | This study is designed as a cohort study. Receives: Device: NEMOST system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronal balance (Correction of the primary curvature on radiograph
Cobb angle (degrees)
Measured: 2 years
T1-S1 length on radiograph
length (cm)
Measured: 2 years
instrument segment length on radiograph
length (cm)
Measured: 2 years
(Serious) Adverse Event
complications
Measured: 2 years
Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle)
Cobb angle (degrees)
Measured: 2 years
Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt)
degrees
Measured: 2 years
Secondary outcomes (2)
Vertebral rotation
scoliometer assesment
Measured: 2 years
Patient Reported Outcome (PRO
Scoliosis Research Society's-22 questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Model description
- Cohort study
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BJ van Royen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- BJ Van Royen, MD, PhD, Principal investigator, AmsterdamUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441411
- Sponsor's protocol ID
- NL67124.018.19
- Other IDs
- NL8659
- Acronym
- NEMOST-AIS
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2020
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Post AM, Berends HI, van Royen BJ. Minimally Invasive Posterior Spinal Nonfusion Surgery in Patients With Adolescent Idiopathic Scoliosis Using a Bipolar One-Way Self-Expanding Rod System: Protocol for a Single-Center Clinical Cohort Study. JMIR Res Protoc. 2023 Dec 25;12:e47222. doi: 10.2196/47222.
PubMed 38145474
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients Using the Nemost-AIS System
- ClinicalTrials.gov ID
- NCT04441411
- Acronym / sponsor ID
- NEMOST-AIS / NL67124.018.19
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- scoliosis, nonfusion, surgery, fusionless, idiopathic, adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jun 2020 (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 primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.
Detailed description
Scoliosis is a complex three-dimensional deformity of the spine, which occurs primarily in growing children and adolescents. In adolescent idiopathic scoliosis (AIS), the cause is unknown. Children with severe and progressive scoliosis, if left untreated, are at risk of rapid and severe spinal deformity progression, which can result in a decrease of pulmonary function, poor cosmetic result and poor quality of life.
Treatment options in AIS depend on curve severity and remaining growth potential, and include intensive brace treatment for smaller curvatures whereas surgical correction and spinal fusion is advocated for more severe curves. Growing rods are used for severe early infantile deformities or early onset scoliosis (EOS).
Bracing, by using a rigid plastic orthosis, is currently the primary therapy to prevent curve progression in mild curves up to 45 degrees and skeletal immature patients. Most braces are recommended to be worn for 18-23 hours per day during several years (until skeletal maturity has been reached). This may cause a high level of physical discomfort and emotional and psychological stress in these patients, and failure of brace treatment therefore is common.
Surgical therapy for AIS is recommended in severe progressive curvatures. Surgical treatment includes correction of the spinal curvature by using multisegmental screw fixation and posterior spinal fusion of the thoracolumbar spine. Complete posterior spinal fusion, however, lacks the possibilities for future adaptation of natural changes in spinal balance and posture.
Currently, growing rods systems are used as a posterior spinal implant to allow growth of the spine and thorax and limit progression of the scoliosis in young patients with early onset scoliosis. Growing rods systems are distractible spinal implants, with bipolar anchorage fixations to the upper and lower part of the spine, using posterior spinal instrumentation such as hooks and pedicle screws.
The Nemost growing system, developed by the EUROS Compagny, is a CE-marked commercial available medical device for the treatment of early onset neuromuscular or early onset idiopathic scoliosis. It is a non-fusion, growth enabling system with bipolar fixation intended to be used with a posterior spinal instrumentation.
It is hypothesized that the use of a minimal invasive non-fusion bipolar posterior spinal implant (Nemost growing domino) can both correct and brace the spine internally and adapt balans and or distraction as the idiopathic scoliosis patient grows.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| NEMOST-AIS | Other | Device: NEMOST systemThis study is designed as a cohort study. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Adolescent idiopathic scoliosis ;
- Primary Cobb angle greater than 30°;
- Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time;
- Skeletally immature (Risser grade* ≤2 and Skeletal age of hand and wrist X-rays ≤14y);
- In girl, either pre-menarchal or post-menarchal by no more than 1 year;
Key exclusion criteria (9 listed)
- Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis);
- History of previous spine surgery;
- Risser sign >2;
- Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality);
- Non-reductible scoliosis;
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 |
|---|---|---|
| NEMOST systemMinimal invasive double rod posterior Non-Fusion Scoliosis Surgery | Device | NEMOST-AIS |
Primary outcome
Coronal balance (Correction of the primary curvature on radiograph
Time frame: 2 years
Cobb angle (degrees)
T1-S1 length on radiograph
Time frame: 2 years
length (cm)
instrument segment length on radiograph
Time frame: 2 years
length (cm)
(Serious) Adverse Event
Time frame: 2 years
complications
Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle)
Time frame: 2 years
Cobb angle (degrees)
Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt)
Time frame: 2 years
degrees
2 secondary outcomes
Vertebral rotation
Time frame: 2 years
Patient Reported Outcome (PRO
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 38145474Post AM, Berends HI, van Royen BJ. Minimally Invasive Posterior Spinal Nonfusion Surgery in Patients With Adolescent Idiopathic Scoliosis Using a Bipolar One-Way Self-Expanding Rod System: Protocol for a Single-Center Clinical Cohort Study. JMIR Res Protoc. 2023 Dec 25;12:e47222. doi: 10.2196/47222.
- 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.
BJ Van Royen, MD, PhD principal investigator
AmsterdamUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEMOST system in people with Adolescent Idiopathic Scoliosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Jul 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BJ Van Royen, MD, PhD (+31(0)5662672, bj.vanroyen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronal balance (Correction of the primary curvature on radiograph (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04441411, which also lists 1 linked publication.
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 30 Jul 2024.