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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 4  |  Page : 164-169

Cobalt alloy pedicle screw implantation for severe kyphosis deformity in spinal tuberculosis: study protocol for a self-controlled trial


1 Affiliated Hospital of Hebei University, Baoding, Hebei Province, China
2 The Third Central Hospital of Baoding City, Baoding, Hebei Province, China

Correspondence Address:
Lin-jie Wang
Affiliated Hospital of Hebei University, Baoding, Hebei Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.194806

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Background: In spinal tuberculosis patients with severe kyphosis deformity, internal fixation via either the anterior or the posterior approach reportedly has good curative effects. However, few prospective, long-term follow-up case control studies have compared the outcome after surgery via the anterior versus the posterior approach. Methods/Design: This is a prospective, single-center, self-controlled, open-label trial that will be performed at the Affiliated Hospital of Hebei University, China. This study will include 84 patients with severe kyphosis deformity in spinal tuberculosis according to diagnostic criteria. Of 52 patients with tuberculosis of the thoracic spine, 28 will undergo surgery via the posterior approach, and 24 via the anterior approach; spinal cord function in these 52 patients has been classified as Frankel grade C (n = 8), D (n = 31) and E (n = 13). Of 32 patients with tuberculosis of the lumbar spine, 16 will undergo surgery via the posterior approach and 16 via the anterior approach; these 32 patients have been classified as Frankel grade C (n = 7), D (n = 14) and E (n = 11). The primary outcome measure of this study will be comparison of the Cobb angle at the thoracic spine segments preoperatively versus 2 years postoperatively (to evaluate the change in thoracic spine curvature). The secondary outcome measures will be X-ray or MRI findings preoperatively versus 2 years postoperatively (to evaluate vertebral body fusion after internal fixation), and Frankel grade preoperatively versus 2 years postoperatively (to evaluate recovery of spinal cord function). Other outcome measures will include multiple logistic regression analysis results of the factors that influence curative effects, and the incidence of adverse events 2 years postoperatively. Discussion: This study aims to validate the curative effects of cobalt alloy pedicle screw implantation in severe kyphosis deformity in spinal tuberculosis, and to determine which internal fixation approach (posterior or anterior) is more beneficial. The results will provide objective long-term follow-up clinical evidence of the efficacy of internal fixation treatment of severe kyphotic deformity in spinal tuberculosis. Trial registration: ClinicalTrials.gov identifier: NCT02971644. Ethics: The trial protocol has been approved by the Ethics Committee, Affiliated Hospital of Hebei University, China and will be performed in strict accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent regarding the trial protocol will be obtained from each participant.


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