O-arm Assessment of Vertebral Movement Using ST2R Technique

Scoliosis; Adolescence Clinical Trial

Official title:

The O-arm Assessment of Vertebral Movement Pre and Post Correction Using ST2R Technique

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03609138
• Other study ID #: #0312
• Status: Withdrawn
• Start date: July 2018
• Est. completion date: July 2022

Study information

• Verified date: November 2023
• Source: Medicrea, USA Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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…)

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis; Adolescence

Intervention

Device:
• Spinal Hardware
Pedicle screws and patient specific rods

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medicrea, USA Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients		4 years
Secondary	Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data		4 years