MESA Rail™ AIS Study - Preservation of Curve Correction

NCT02062606 | Terminated Results DMC

• 1 other identifier: CA-001
• Study Type: observational
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Scoliosis; Spinal Curvatures; Spinal Diseases; Adolescent Idiopathic Scoliosis; Spinal Deformity

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months

  Restoration and maintenance of thoracic kyphosis and coronal curve correction. Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.

  Baseline (up to 90 days before surgery), 24 months

• Number of Participants With Adverse Events

  Number of participants with SAE and AE for the various intervals

  Up to 24 months

Secondary Outcomes (10)

• Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months

  Baseline (up to 90 days before surgery), 24 months

• Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months

  Baseline (up to 90 days before surgery), 24 months

• Patient Satisfaction

  12 months and 24 months

• Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria

  24 months

• Length of Surgery Time

  During surgery

Study Arms (1)

AIS

Surgical implantation of the K2M MESA Rail™ Deformity System in the treatment of Adolescent Idiopathic Scoliosis (AIS).

Device: MESA Rail™ Deformity System

Interventions

MESA Rail™ Deformity System DEVICE

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

AIS

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• K2M, Inc.: lead

Related Publications (3)

• Wattenbarger JM, Richards BS, Herring JA. A comparison of single-rod instrumentation with double-rod instrumentation in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1680-8. doi: 10.1097/00007632-200007010-00011.

  PMID: 10870143 BACKGROUND

• Newton PO, Yaszay B, Upasani VV, Pawelek JB, Bastrom TP, Lenke LG, Lowe T, Crawford A, Betz R, Lonner B; Harms Study Group. Preservation of thoracic kyphosis is critical to maintain lumbar lordosis in the surgical treatment of adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2010 Jun 15;35(14):1365-70. doi: 10.1097/BRS.0b013e3181dccd63.

  PMID: 20505560 BACKGROUND

• Kim YJ, Lenke LG, Bridwell KH, Kim J, Cho SK, Cheh G, Yoon J. Proximal junctional kyphosis in adolescent idiopathic scoliosis after 3 different types of posterior segmental spinal instrumentation and fusions: incidence and risk factor analysis of 410 cases. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2731-8. doi: 10.1097/BRS.0b013e31815a7ead.

  PMID: 18007253 BACKGROUND

MeSH Terms

Conditions

Scoliosis; Spinal Curvatures; Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Marissa Conrad, Senior Director of Clinical and Medical Affairs
• Organization: Stryker Spine

marissa.conrad@stryker.com

201-749-8162

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 13, 2014
• Study Start: May 1, 2014
• Primary Completion: February 23, 2020
• Study Completion: February 23, 2020
• Last Updated: April 12, 2021
• Results First Posted: April 12, 2021

Record last verified: 2021-04