O-arm Assessment of Vertebral Movement Using ST2R Technique

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03609138

Enrollment

Registered

2018-08-01

Start date

2018-07-31

Completion date

2022-07-31

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis; Adolescence

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.

Interventions

DEVICESpinal Hardware

Pedicle screws and patient specific rods

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 21 Years

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…)

Design outcomes

Primary

Measure	Time frame
Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients	4 years

Secondary

Measure	Time frame
Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data	4 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026