Non fusion surgery in adolescent idiopathic scoliosis patients using the Nemost system

Non fusion surgery in adolescent idiopathic scoliosis patients using the Nemost system - Non fusion surgery in AIS patients / NEMOST-AIS study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49966

Enrollment

Registered

2020-05-19

Start date

2021-11-17

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis Spinal deformity

Interventions

Application of Nemost-AIS

Eligibility

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Adoleschent idiopathic scoliosis patients (7-16 years); 2. Pre menarch, or up to 6 months post menarch; 3. Standing x-ray: 25 to 55 degrees Cobb angle, Lenke 1 to 6, Risser stage 0

Exclusion criteria

Exclusion criteria: 1. Previous spine surgery; 2. Other non-idiopathic forms of scoliosis; 3. Primary curve with a Cobb > 55 degrees; 4. Known allergy to titanium; 5. Active systemic disease, such as AIDS, HIV, or active infection 6. Systemic disease that would affect the subject's wellfare or overall outcome of the study, or; 7. Mentally compromised.

Design outcomes

Primary

Measure	Time frame
- Efficacy: Primary endpoint: Correction of primary curve Cobb angle at 2 years after skeletal maturity. Subgoals 1. Correction of curvature directly after implantation of Nemost-AIS (Cobb angle preoperative vs Cobb angle directly postoperative 2. Enabled growth (T1-S1 length, lengthening of Nemost-AIS) 3. Correction of curvature at maturity (Cobb angle preoperative vs Cobb angle at maturity) - Safety: Treatment related complications as (Serious) Adverse Event rate, reoperation rate, spine arthrodesis.	—

Measure

Time frame

- Efficacy: Primary endpoint: Correction of primary curve Cobb angle at 2 years after skeletal maturity. Subgoals 1. Correction of curvature directly after implantation of Nemost-AIS (Cobb angle preoperative vs Cobb angle directly postoperative 2. Enabled growth (T1-S1 length, lengthening of Nemost-AIS) 3. Correction of curvature at maturity (Cobb angle preoperative vs Cobb angle at maturity) - Safety: Treatment related complications as (Serious) Adverse Event rate, reoperation rate, spine arthrodesis.

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Secondary

Measure	Time frame
Effectiveness Radiological assessments: * Coronal balance (pimary and secondary curve Cobb angle) ; * Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle); * Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt) * Vertebral rotation based on PA X-Ray Clinical assessments: * Patient appearance: shoulder imbalance, pelvic imbalance, gibbosity, vertebral rotation (based on scoliometer assesment) * Patient Reported Outcome (PRO) - SRS-22 (The Scoliosis Research Society*s-22 questionnaire measures multiple domains as pain, self-image, function, and satisfaction with management).	—

Measure

Time frame

Effectiveness Radiological assessments: * Coronal balance (pimary and secondary curve Cobb angle) ; * Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle); * Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt) * Vertebral rotation based on PA X-Ray Clinical assessments: * Patient appearance: shoulder imbalance, pelvic imbalance, gibbosity, vertebral rotation (based on scoliometer assesment) * Patient Reported Outcome (PRO) - SRS-22 (The Scoliosis Research Society*s-22 questionnaire measures multiple domains as pain, self-image, function, and satisfaction with management).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)