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Clinical Trials/NCT04992845
NCT04992845
Terminated
Not Applicable

Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period

Spino Modulation Inc.1 site in 1 country44 target enrollmentStarted: April 15, 2019Last updated:
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ConditionsAdolescent Idiopathic ScoliosisJuvenile Idiopathic Scoliosis

Overview

Phase
Not Applicable
Status
Terminated
Sponsor
Spino Modulation Inc.
Enrollment
44
Locations
1
Primary Endpoint
Change in Cobb angle measurement
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
9 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Diagnosis of juvenile or adolescent idiopathic scoliosis
  • •Male and female subjects greater than 8 years of age with significant growth remaining
  • •Risser Stage 0 or 1
  • •Subjects should have at least three years of estimated growth remaining based on Risser staging
  • •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
  • •Thoracic kyphosis (T5-T12) \< 50°
  • •Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive)
  • •Menses \< 4 months
  • •Subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations
  • •Subject assent and parent/legal guardian consent obtained and documented.

Exclusion Criteria

  • •Scoliosis curve is less than 30° or more than 70°
  • •Thoracic kyphosis is greater than or equal to 50° (T5-T12)
  • •The vertebrae to be instrumented is less than 12mm in height (based on the staple size)
  • •One of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length)
  • •One of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length)
  • •Non-idiopathic scoliosis
  • •Non-ambulatory
  • •Subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget's disease and metabolic bone disease
  • •Prior thoracic surgery
  • •Abnormal neurological status at baseline

Outcomes

Primary Outcomes

Change in Cobb angle measurement

Time Frame: 12 months

The change in Cobb angle measurement from baseline (preoperative) to 12 months

Rate of device- &/or procedure-related SAEs

Time Frame: 12 months

Rate of positively adjudicated device or procedure related serious adverse events including subsequent secondary surgical intervention and neurological events from baseline (preoperative) through 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Spino Modulation Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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