O-arm Assessment of Vertebral Movement Using ST2R Technique
Withdrawn
- Conditions
- Scoliosis; Adolescence
- Interventions
- Device: Spinal Hardware
- Registration Number
- NCT03609138
- Lead Sponsor
- Medicrea, USA Corp.
- Brief Summary
The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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...)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Cohort Spinal Hardware -
- Primary Outcome Measures
Name Time Method Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients 4 years
- Secondary Outcome Measures
Name Time Method Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data 4 years