Safety and Efficacy Evaluation of Insight GS Growing System

Official title

Safety and Efficacy Evaluation of Insight GS Growing System in the Surgical Treatment of Early Onset Scoliosis (EOS)

Overview

Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE). Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study. Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events.

Interventions

• Device Insight GS
  The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and ar

Primary outcome measures

• Coronal Cobb angle change 24 months after installation of the Insight GS system. [Time frame: 24 months after Insight GS System placement]

Secondary outcome measures (4)

• Number of Adverse event ocurrence assessed by clinical evaluation [Time frame: 24 months after Insight GS System placement]
• Changes in patient's trunk height assessed by T1 to T12 distance and the T1 to S1 distance on full-spine radiographs [Time frame: 24 months after Insight GS System placement]
• Patients' pain assessed by Wong-Baker non-verbal facial scale [Time frame: 24 months after Insight GS System placement]
• Patient's satisfaction assessed by EOSQ-24 scale [Time frame: 24 months after Insight GS System placement]

Eligibility criteria

Inclusion criteria

• TCLE signed by parents
• Ages 3 to 10 years, or Risser 0, or Sanders 1,2,3 and 4
• Cobb angle bigger than 30°
• Thoracic spine height T1-T12 less than 22 centimeters
• Risk of thoracic insufficiency syndrome (TIS).

Exclusion criteria

• Need for fixation at occipital or cervical levels
• Risser sign greater than or equal to 1
• Sanders bigger than 4
• Previous spine surgery
• Medullary abnormalities
• Existence of malignant processes
• Local or systemic inflammations and infections, acute or chronic
• Allergy or intolerance to materials
• Non-reducible scoliosis
• Morbid obesity
• Insufficiency or absence of skin coverage

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Hospital Ortopédico AACD — São Paulo

Publications

• Mehdian H, Haddad S, Pasku D, Nasto LA. Mid-term results of a modified self-growing rod technique for the treatment of early-onset scoliosis. Bone Joint J. 2020 Nov;102-B(11):1560-1566. doi: 10.1302/0301-620X.102B11.BJJ-2020-0412.R3. PMID 33135451
• AlNouri M, Wada K, Kumagai G, Asari T, Nitobe Y, Morishima T, Uesato R, Aoki M, Ishibashi Y. Diseases and comorbidities associated with early-onset scoliosis: a retrospective multicenter analysis. Spine Deform. 2023 Mar;11(2):481-486. doi: 10.1007/s43390-022-00613-6. Epub 2022 Nov 16. PMID 36380109
• Ruiz G, Torres-Lugo NJ, Marrero-Ortiz P, Guzman H, Olivella G, Ramirez N. Early-onset scoliosis: a narrative review. EFORT Open Rev. 2022 Aug 4;7(8):599-610. doi: 10.1530/EOR-22-0040. PMID 35924646
• McCarthy RE, Luhmann S, Lenke L, McCullough FL. The Shilla growth guidance technique for early-onset spinal deformities at 2-year follow-up: a preliminary report. J Pediatr Orthop. 2014 Jan;34(1):1-7. doi: 10.1097/BPO.0b013e31829f92dc. PMID 23934092
• Sankar WN, Skaggs DL, Yazici M, Johnston CE 2nd, Shah SA, Javidan P, Kadakia RV, Day TF, Akbarnia BA. Lengthening of dual growing rods and the law of diminishing returns. Spine (Phila Pa 1976). 2011 May 1;36(10):806-9. doi: 10.1097/BRS.0b013e318214d78f. PMID 21336236
• Luhmann SJ, McCarthy RE. A Comparison of SHILLA GROWTH GUIDANCE SYSTEM and Growing Rods in the Treatment of Spinal Deformity in Children Less Than 10 Years of Age. J Pediatr Orthop. 2017 Dec;37(8):e567-e574. doi: 10.1097/BPO.0000000000000751. PMID 27043203
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Identifiers

NCT: NCT06301984 · ANDROMEDA_01_2023_V1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗