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Clinical Trials/NCT03609138
NCT03609138WithdrawnNot Applicable

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

Medicrea, USA Corp.0 sitesStarted: July 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
10 Years to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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...)

Outcomes

Primary Outcomes

Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients

Time Frame: 4 years

Secondary Outcomes

  • Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data(4 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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