O-arm Assessment of Vertebral Movement Using ST2R Technique

Medicrea, USA Corp.

Overview

The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.

Visits include the pre-operative visit, 1 and 2 year follow-up visits. Participation includes answering questions and filling out questionnaires. There are no immediate benefits by joining this study, but could potentially help define better techniques for the future spine surgeries. The risks involved in this study are minimal and there are no alternatives to this study.

Study Type

OBSERVATIONAL

Conditions

Scoliosis; Adolescence

Interventions

Spinal HardwareDEVICE

Pedicle screws and patient specific rods

Eligibility

Sex: ALLMin age: 10 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adolescent idiopathic scoliosis requiring selective thoracic posterior spinal instrumentation and fusion with the PASS LP system (screws, rods, hooks) and UNiD rod technology * Age between 10 and 21 * Lenke Type 1 curve * Consent and Assent to participate in the study Exclusion Criteria: * Age superior to 21 years * Spinal deformities other than Lenke 1 type * Use of implant other than those from the PASS LP system or sublaminar bands * Neuromuscular or degenerative scoliosis * Spinal cord abnormalities with any neurologic symptoms or signs * Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression * Primary muscle diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, Cerebral palsy, or Spina bidifa, Neurofibroma) * Primary abnormalities of bones (e.g. osteogenesis imperfect) * Congenital Scoliosis * Scoliosis requiring anterior release * Previous spinal surgery * Absence of required preoperative data (diagnosis, consent…)

Outcomes

Primary Outcomes

Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients

Time frame: 4 years

Secondary Outcomes

Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data

Time frame: 4 years

Data from ClinicalTrials.gov

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