O-arm Assessment of Vertebral Movement Using ST2R Technique

November 23, 2023 updated by: Medicrea, USA Corp.

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with adolescent idiopathic scoliosis undergoing fusion surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Cohort
Device: Spinal Hardware
Pedicle screws and patient specific rods

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicrea, USA Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2018

Primary Completion (Estimated)

July 1, 2020

Study Completion (Estimated)

July 1, 2022

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #0312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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