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MESA Rail™ AIS Study - Preservation of Curve Correction

NCT02062606 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 188

Last updated 2021-04-12

Study results available
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Summary

To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic Scoliosis (AIS).

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

DEVICE

MESA Rail™ Deformity System

MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature

Sponsors & Collaborators

  • K2M, Inc.

    lead INDUSTRY

Eligibility

Min Age
11 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2020-02-23
Completion
2020-02-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02062606 on ClinicalTrials.gov