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
About this trial
This is an interventional treatment trial for Spinal Tuberculosis
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
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
NCT ID
NCT02971644
First Posted
November 14, 2016
Last Updated
November 20, 2016
Sponsor
Affiliated Hospital of Hebei University
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
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Cobalt Alloy Pedicle Screw Implantation for Severe Kyphosis Deformity in Spinal Tuberculosis
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