Safety and Efficacy Evaluation of Insight GS Growing System

NCT ID: NCT06301984

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-08-31

Brief Summary

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.

Conditions

Early Onset Scoliosis (EOS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

In the initial assessment, data regarding the general health status will be collected and imaging exams (panoramic X-ray of the anteroposterior, lateral and traction spine, and X-ray of the right and left hands) and laboratory tests (blood count, coagulogram, dosage of sodium and potassium, urea and creatinine levels, AST and ALT, PCR, ESR, type I urine and urine culture) will be requested. During the preoperative consultation, measurements of the study variables will be obtained from the imaging exams), in addition to obtaining photographs of the patients. To install the Insight GS system, the surgical approach will be carried out according to the manufacturer's instructions for use, briefly described below. A posterior midline skin incision is made from the upper to the lower instrumented level. Subfascial exposure of the spine is performed, ensuring that the facet joint capsules are spared. Pedicle screws are inserted bilaterally at the cranial and caudal ends of the instrumentati

Group Type: EXPERIMENTAL

Insight GS

Intervention Type: DEVICE

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).

Interventions

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 are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EVEREST PESQUISA E DESENVOLVIMENTO LTDA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Ortopédico AACD

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Mariana F Goncalves

Role: CONTACT

mfgoncalves@aacd.org.br

+55 11 99117-6507

Facility Contacts

Mariana F Goncalves

Role: primary

mfgoncalves@aacd.org.br

References

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.

Reference Type: BACKGROUND

PMID: 33135451 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36380109 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35924646 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23934092 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21336236 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27043203 (View on PubMed)

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Reference Type: BACKGROUND

Other Identifiers

ANDROMEDA_01_2023_V1

Identifier Type: -

Identifier Source: org_study_id