Cobalt alloy pedicle screw implantation for treatment of severe kyphotic deformity in spinal tuberculosis:study protocol for a self-control trial / 中国组织工程研究

ABSTRACT

BACKGROUND:There is evidence that internal fixation through an anterior or posterior approach for treatment of severe kyphotic deformity in spinal tuberculosis exhibits good curative effects. However, few prospective, long-term fol ow-up case control studies are reported. OBJECTIVE:To investigate the efficacy and safety of cobalt al oy pedicle screw implantation for treatment of severe kyphotic deformity in spinal tuberculosis. METHODS/DESIGN:This is a prospective, single-center, self-control, open-label trial, which wil be performed at the Affiliated Hospital of Hebei University, China. Eighty-four patients with severe kyphotic deformity in spinal tuberculosis wil be included according to the diagnosis criteria. Among 52 patients with tuberculosis of the thoracic spine, 28 wil undergo surgery through a posterior approach, and 24 through an anterior approach. According to the Frankel Grade classification, grade C, D and E spinal cord function wil be assessed in 8, 31 and 13 patients, respectively. Surgery through a posterior and anterior approach wil be respectively performed in half of 32 patients with tuberculosis of the lumbar spine. Grade C, D and E spinal cord function wil be assessed in 7, 14 and 11 patients, respectively. The primary outcome measure of this study wil be the Cobb angle at the thoracic spine segments before and 2 years after surgery, which wil be used to evaluate the angle of the spine curvature at the thoracic segments. The secondary outcome measures wil be X-ray scan or MRI findings before and 2 years after surgery, which wil be used to evaluate vertebral fusion after internal fixation;and Frankel Grade before and 2 years after surgery, which wil be used to evaluate recovery of spinal cord function after injury. Other outcome measures wil include multiple logistic regression analysis results of the factors that influence patient's curative effects and the incidence of adverse events 2 years after surgery. The trial protocol has been approved by the Ethics Committee, Affiliated Hospital of Hebei University, China and wil be performed in strict accordance with the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding the trial protocol wil be obtained from each participant. DISCUSSION:This study is to validate that cobalt al oy pedicle screw implantation shows precise curative effects in the treatment of severe kyphotic deformity in spinal tuberculosis and to analyze through what approach, posterior or anterior, internal fixation wil be more beneficial to surgery performance. The outcomes of this study wil provide objective long-term fol ow-up evidence for internal fixation treatment of severe kyphotic deformity in spinal tuberculosis in the clinic.