Spine Surgery for Lenke 1 Adolescent Idiopathic Scoliosis

Condition(s) studied

Investigational drug(s) / intervention(s)

single rod: surgical correction of severe adolescent idiopathic scoliosis with screws and a single rod.

Study summary

Idiopathic scoliosis of developmental age (AIS) is the most vertebral deformity in the adolescent population, with a prevalence of 1-3%. The treatment of AIS depends on the morphology and extent of the curve and the growth potential residual, can range from simple clinical-radiological monitoring, to the use of braces to, in the most severe cases, correction surgical correction. The indication for surgical correction of AIS depends on the location, extent and flexibility of the scoliotic curve and not least on the patient's age or, better, the skeletal age. The primary goal of surgery is to correcting the deformity by preventing its progression, preserving as many motion segments as possible; secondarily, the surgery aims to restore the coronal and sagittal balance of the spine.

Eligibility

Primary outcome measure(s)

• Spine Correction — at baseline
  The correction of the curvature of the back will be evaluated via x-ray
• Spine Correction — at 12 months
  The correction of the curvature of the back will be evaluated via x-ray
• Quality of Life 1 — at baseline
  The "Scoliosis Research Society 22" is a multidimensional questionnaire covering the four non-management domains of pain, function, self-image, and mental health (5 items per domain), along with 2 items to assess the patient's satisfaction with management of their deformity
• Quality of Life 1 — at 12 months
  The "Scoliosis Research Society 22" is a multidimensional questionnaire covering the four non-management domains of pain, function, self-image, and mental health (5 items per domain), along with 2 items to assess the patient's satisfaction with management of their deformity
• Quality of Life 2 — at baseline
  The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from back pain.
• Quality of Life 2 — at 12 months
  The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from back pain.

Trial sites (1)

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