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

NCT02971644 | Unknown DMC

• 1 other identifier: HebeiU_001
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Cobb angle

  A greater Cobb angle indicates more severe kyphosis deformity.

  2 years postoperatively

Secondary Outcomes (2)

• X-ray image

  baseline and 2 years postoperatively

• Frankel Grade

  baseline and 2 years postoperatively

Study Arms (1)

cobalt alloy pedicle screw implantation

EXPERIMENTAL

The spinal tuberculosis patients with severe kyphosis deformity who will undergo cobalt alloy pedicle screw implantation.

Device: cobalt alloy pedicle screw implantation

Interventions

cobalt alloy pedicle screw implantation DEVICE

The patients with severe kyphosis deformity undergo cobalt alloy pedicle screw implantation.

cobalt alloy pedicle screw implantation

Eligibility Criteria

• Age: 24 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to tolerate surgery
• Other concomitant spine diseases
• Unable or unwilling to participate in this clinical trial

Sponsors & Collaborators

• Affiliated Hospital of Hebei University: lead

MeSH Terms

Conditions

Tuberculosis, Spinal

Condition Hierarchy (Ancestors)

Tuberculosis, Osteoarticular; Tuberculosis, Extrapulmonary; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Spondylitis; Spinal Diseases

Study Officials

• Yu Hou, Master

  Affiliated Hospital of Hebei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 23, 2016
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11