Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02971644 |
| Other study ID # |
HebeiU_001 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
November 14, 2016 |
| Last updated |
November 20, 2016 |
| Start date |
December 2014 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
November 2016 |
| Source |
Affiliated Hospital of Hebei University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
China: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial 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.
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.
