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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Cobalt Alloy Pedicle Screw Implantation for Severe Kyphosis Deformity in Spinal Tuberculosis: a Selfcontrolled Trial

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 Summary:

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 stre
Sponsor: Affiliated Hospital of Hebei University

Current Primary Outcome: Cobb angle [ Time Frame: 2 years postoperatively ]

A greater Cobb angle indicates more severe kyphosis deformity.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • X-ray image [ Time Frame: baseline and 2 years postoperatively ]
    Anterior-posterior X-ray images of the scoliotic spine will be taken using a digital X-ray scanner.
  • Frankel Grade [ Time Frame: baseline and 2 years postoperatively ]
    To evaluate the recovery of spinal cord function. The Frankel Grade classification is used to assess the severity of spinal cord injury.


Original Secondary Outcome: Same as current

Information By: Affiliated Hospital of Hebei University

Dates:
Date Received: November 14, 2016
Date Started: December 2014
Date Completion: December 2016
Last Updated: November 20, 2016
Last Verified: November 2016