O-arm Assessment of Vertebral Movement Using ST2R Technique

Medicrea

Status: Withdrawn

Conditions: Scoliosis; Adolescence

Treatments: Device: Spinal Hardware

Study type: Observational

Funder types: Industry

Identifiers

NCT03609138

#0312

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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...)

Trial design

0 participants in 1 patient group

Study Cohort

Treatment:

Device: Spinal Hardware