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O-arm Assessment of Vertebral Movement Using ST2R Technique

NCT ID: NCT03609138

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Scoliosis; Adolescence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Cohort

Spinal Hardware

Intervention Type DEVICE

Pedicle screws and patient specific rods

Interventions

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Spinal Hardware

Pedicle screws and patient specific rods

Intervention Type DEVICE

Eligibility Criteria

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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…)
Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medicrea, USA Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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#0312

Identifier Type: -

Identifier Source: org_study_id