Trial record 7 of 30 for:    "adolescent idiopathic scoliosis"

MESA Rail™ AIS Study - Preservation of Curve Correction

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by K2M, Inc.
Sponsor:
Information provided by (Responsible Party):
K2M, Inc.
ClinicalTrials.gov Identifier:
NCT02062606
First received: January 31, 2014
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
Adolescent Idiopathic Scoliosis
Device: MESA Rail™ Deformity System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preservation of Thoracic Kyphosis and Coronal Curve Correction as a Function of Rod Stiffness in the Surgical Treatment of Adolescent Idiopathic Scoliosis With the Use of the K2M MESA Rail™ Deformity System

Resource links provided by NLM:


Further study details as provided by K2M, Inc.:

Primary Outcome Measures:
  • Change from baseline in Cobb Angles on x-ray at 24 months [ Time Frame: Baseline (up to 90 days before surgery), 24 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in pain scores on the Visual Analog Scale (VAS) at 24 months [ Time Frame: Baseline (up to 90 days before surgery), 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life scores on the SRS-22r at 24 months [ Time Frame: Baseline (up to 90 days before surgery), 24 months ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 12 months, 24 months ] [ Designated as safety issue: No ]
  • Investigator's rating of subject's clinical disposition using Odom's Criteria [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Length of Surgery Time [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    The length of the surgical procedure from the initial incision to final closure will be captured.

  • Length of Anesthesia Time [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    The length of time the patient is under anesthesia will be captured.

  • Estimated Blood Loss [ Time Frame: At time of surgery ] [ Designated as safety issue: Yes ]
    The amount of blood loss over the entire length of the surgery will be captured.

  • Length of Hospital Stay [ Time Frame: An expected average of 5 days after the date of surgery ] [ Designated as safety issue: No ]
    The length of the hospital stay from the date of admission to the date of discharge.

  • Time to Return to Work/School [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery will be documented.

  • Use of narcotics post-surgery [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    The types and dosages of any narcotics taken by the patient post-surgery will be documented.


Estimated Enrollment: 204
Study Start Date: February 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AIS
Surgical implantation of the K2M MESA Rail™ Deformity System in the treatment of Adolescent Idiopathic Scoliosis (AIS).
Device: MESA Rail™ Deformity System
MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature

Detailed Description:

Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail™ Deformity System that had:

Diagnosis of AIS requiring surgical treatment for selective non-cervical fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies.

AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles will be noted but not restrictive).

Age at time of surgery of ≥ 11 years old and ≤ 21 years old.

  Eligibility

Ages Eligible for Study:   11 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Two-hundred four (204) total subjects with the MESA Rail Deformity System at up to 18 clinical sites, geographically distributed worldwide.

Criteria

Inclusion Criteria:

  • Diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve. No cervical vertebrae are to be incorporated into the construct.
  • Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
  • Willing and able to sign a study specific informed consent form or, in the case of a patient who is a minor, provide assent and the minor patient's parent/legal guardian provides written consent to participate.
  • Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.

Exclusion Criteria:

  • Previous anterior or posterior spine surgery at the index levels.
  • Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.
  • Active systemic infection or infection at the operative site.
  • Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.
  • Metabolic bone disease such as osteoporosis that contradicts spinal surgery.
  • History of an osteoporotic fracture.
  • History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
  • Taking medications that may interfere with bony/soft tissue healing including chronic steroid use.
  • Known allergy to titanium or cobalt chrome.
  • Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
  • Insulin-dependent type 1 or type 2 diabetes.
  • Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
  • Pregnant, or intend to become pregnant, during the course of the study.
  • Severe obesity (Body Mass Index > 40).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062606

Contacts
Contact: Stephanie Bollinger sbollinger@k2m.com
Contact: Dawn Tolbert dtolbert@k2m.com

Sponsors and Collaborators
K2M, Inc.
  More Information

Publications:
Responsible Party: K2M, Inc.
ClinicalTrials.gov Identifier: NCT02062606     History of Changes
Other Study ID Numbers: CA-001
Study First Received: January 31, 2014
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board
New Zealand: Ethics Committee
United Kingdom: Research Ethics Committee
Australia: Human Research Ethics Committee

Keywords provided by K2M, Inc.:
Scoliosis
Spinal Curvatures
Spinal Diseases
Adolescent Idiopathic Scoliosis
Spinal Deformity

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 23, 2014