search
Back to results

Cobalt Alloy Pedicle Screw Implantation for Severe Kyphosis Deformity in Spinal Tuberculosis

Primary Purpose

Spinal Tuberculosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cobalt alloy pedicle screw implantation
Sponsored by
Affiliated Hospital of Hebei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Tuberculosis

Eligibility Criteria

24 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meeting the diagnostic criteria of spinal tuberculosis
  • Diagnosed with spinal tuberculosis via X-ray or MRI
  • Spinal tuberculosis patients with severe kyphosis deformity at the thoracic and lumbar segments and a spinal Cobb angle ≥ 90° complicated by spinal cord compression or neurological dysfunction, spinal stability destruction and paravertebral abscess
  • Frankel grade C, D, or E
  • Age 24-67 years
  • Provision of complete medical data
  • Receiving anti-tuberculosis medication for 3 weeks

Exclusion Criteria:

  • Inability to tolerate surgery
  • Other concomitant spine diseases
  • Unable or unwilling to participate in this clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    cobalt alloy pedicle screw implantation

    Arm Description

    The spinal tuberculosis patients with severe kyphosis deformity who will undergo cobalt alloy pedicle screw implantation.

    Outcomes

    Primary Outcome Measures

    Cobb angle
    A greater Cobb angle indicates more severe kyphosis deformity.

    Secondary Outcome Measures

    X-ray image
    Anterior-posterior X-ray images of the scoliotic spine will be taken using a digital X-ray scanner.
    Frankel Grade
    To evaluate the recovery of spinal cord function. The Frankel Grade classification is used to assess the severity of spinal cord injury.

    Full Information

    First Posted
    November 14, 2016
    Last Updated
    November 20, 2016
    Sponsor
    Affiliated Hospital of Hebei University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02971644
    Brief Title
    Cobalt Alloy Pedicle Screw Implantation for Severe Kyphosis Deformity in Spinal Tuberculosis
    Official Title
    Cobalt Alloy Pedicle Screw Implantation for Severe Kyphosis Deformity in Spinal Tuberculosis: a Selfcontrolled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Affiliated Hospital of Hebei University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To investigate whether implantation of cobalt alloy pedicle screws is effective in treating severe kyphosis deformity in spinal tuberculosis, and to determine the factors that are likely to have influenced the curative effects.
    Detailed Description
    History and current related studies The incidence of spinal tuberculosis has continually increased in recent years; this disease commonly occurs in the lumbar spine, lumbar vertebrae, thoracic vertebrae, and cervical vertebrae. The majority of spinal tuberculosis patients present with kyphosis deformity in corresponding segments. In spinal tuberculosis patients with severe kyphotic deformity, the key to successful treatment is the individual patient's response to tuberculosis drugs and the implementation of rational fixation approaches at an appropriate time; good curative effects have been shown using anterior or posterior fixation, followed by posterior debridement and bone graft fusion. Surgery via the posterior or anterior approach will be respectively performed in 16 of 32 patients with tuberculosis of the lumbar spine. The spinal cord function of these 32 patients has been assessed as Frankel grade C (n = 7), D (n = 14) and E (n = 11). The primary outcome measure of this study will be the Cobb angle at the thoracic spine segments preoperatively versus 2 years postoperatively, which will be used to evaluate the postoperative change in the thoracic spine curvature. The primary causes of poor healing or recurrence of spinal tuberculosis at the thoracic and lumbar segments are reportedly improper surgical timing, poor debridement, improper selection of internal fixation methods, poor selection of bone graft material or grafting position, irregular anti-tuberculosis bacilli chemotherapy, drug tolerance, poor braking, and not using a brace after surgery. However, the factors that influence curative effects require further investigation. Pedicle screws are commonly used to repair spine fracture, and therefore they should have good biocompatibility. Cobalt alloy reportedly exhibits good anti-bending and anti-compressive strength, strong impact toughness, good elastic modulus, small thermal expansion coefficient, and good compatibility with the human body. However, few studies have investigated the use of cobalt alloy pedicle screws for treatment of severe kyphosis deformity in spinal tuberculosis. Adverse events The investigators will record adverse events, including vertebral body displacement, thoracic and lumbar back muscle injury, nonspecific low back pain, and screw pull out or loosening. If severe adverse events occur, investigators will report details, including the data of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours. Data collection, management, analysis and open-access Data collection: Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events will be collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy. Data management: The locked electronic database will be accessible and locked only by the project manager, and will not be altered. All data regarding this trial will be preserved by the Affiliated Hospital of Hebei University, China. Data analysis: The electronic database will be statistically analyzed by a professional statistician who will create an outcome analysis report that will be submitted to the lead researchers. An independent data monitoring committee will supervise the mange the trial data, ensuring a scientific and stringent trial to yield accurate and complete data. Data open access: Anonymized trial data will be published at www.figshare.com. Statistical analysis Statistical analysis will be performed using SPSS 19.0 software, and will follow the intention-to-treat principle. Normally distributed measurement data will be expressed as mean ± standard deviation, and minimums and maximums. Non-normally distributed measurement data will be expressed as lower quartile (q1), and median and upper quartile (q3). The Wilcoxon matched pairs test will be performed for comparison of the Cobb angle preoperatively versus 2 years postoperatively. The Wilcoxon signed-rank test will be performed for comparison of pre- and post-operative Frankel grade, and McNemar's chi-squared test will be used to analyze the incidence of adverse reactions. Multiple logistic regression analysis will be performed to analyze the factors that influence curative effects, with calculation of regression coefficients, odd ratios and 95% confidence interval. The significance level will be α = 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Tuberculosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    cobalt alloy pedicle screw implantation
    Arm Type
    Experimental
    Arm Description
    The spinal tuberculosis patients with severe kyphosis deformity who will undergo cobalt alloy pedicle screw implantation.
    Intervention Type
    Device
    Intervention Name(s)
    cobalt alloy pedicle screw implantation
    Intervention Description
    The patients with severe kyphosis deformity undergo cobalt alloy pedicle screw implantation.
    Primary Outcome Measure Information:
    Title
    Cobb angle
    Description
    A greater Cobb angle indicates more severe kyphosis deformity.
    Time Frame
    2 years postoperatively
    Secondary Outcome Measure Information:
    Title
    X-ray image
    Description
    Anterior-posterior X-ray images of the scoliotic spine will be taken using a digital X-ray scanner.
    Time Frame
    baseline and 2 years postoperatively
    Title
    Frankel Grade
    Description
    To evaluate the recovery of spinal cord function. The Frankel Grade classification is used to assess the severity of spinal cord injury.
    Time Frame
    baseline and 2 years postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meeting the diagnostic criteria of spinal tuberculosis Diagnosed with spinal tuberculosis via X-ray or MRI Spinal tuberculosis patients with severe kyphosis deformity at the thoracic and lumbar segments and a spinal Cobb angle ≥ 90° complicated by spinal cord compression or neurological dysfunction, spinal stability destruction and paravertebral abscess Frankel grade C, D, or E Age 24-67 years Provision of complete medical data Receiving anti-tuberculosis medication for 3 weeks Exclusion Criteria: Inability to tolerate surgery Other concomitant spine diseases Unable or unwilling to participate in this clinical trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu Hou, Master
    Organizational Affiliation
    Affiliated Hospital of Hebei University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Cobalt Alloy Pedicle Screw Implantation for Severe Kyphosis Deformity in Spinal Tuberculosis

    We'll reach out to this number within 24 hrs