ISRCTN10892409已完成未知
Fusionless treatment of idiopathic scoliosis with the MIScoli™ system during the growth period (FUTURE)
Spino Modulation Inc0 个研究点目标入组 59 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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
研究者
相似试验
已完成
4 期
Idiopathic scoliosis (IS): Reduction of scoliosis progression by improving muscle function and muscle strength with vibratioM41.1Juvenile idiopathic scoliosisDRKS00010657Klinik und Poliklinik für Kinder- und JugendmedizinUniversität Köln40
终止
不适用
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth PeriodAdolescent Idiopathic ScoliosisJuvenile Idiopathic ScoliosisNCT04992845Spino Modulation Inc.44
招募中
不适用
Anti-fibrotic treatment in patients with idiopathic pulmonary fibrosis:A cohort studyidiopathic pulmonary fibrosisJPRN-UMIN000020392niversity of Occupational and Environmental Health, Japan100
招募中
不适用
on Fusion Surgery in Adolescent Idiopathic Scoliosis patientsNL-OMON29064not applicable28
招募中
不适用
on fusion surgery in adolescent idiopathic scoliosis patients using the Nemost systemSpinal deformity1002837710005944ScoliosisNL-OMON49966Academisch Medisch Centrum18