NCT02638272

Brief Summary

Whether radical debridement is necessary for the treatment of thoracic and lumbar tuberculosis is still questionable. The objective of this prospective randomized study was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

5.1 years

First QC Date

December 9, 2015

Last Update Submit

December 18, 2015

Conditions

Spinal Tuberculosis

Outcome Measures

Primary Outcomes (4)

  • The operative time in minutes

    5 years

  • blood loss in milliliter

    5 years

  • erythrocyte sedimentation rate (ESR) in mm/h

    5 years

  • kyphotic angle in degree

    5 years

Study Arms (1)

spine surgery

OTHER

The objective was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis.

Procedure: no debridement

Interventions

no debridementPROCEDURE

It is a spinal surgery performed with isolated posterior instrumentation without debridement.

spine surgery

Eligibility Criteria

Age14 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Frankel grading was grade D and E
  • Severe back pain
  • Abscess combined with high pressure symptoms
  • Larger sequestrum formation or sinus
  • Significant spinal instability.

You may not qualify if:

  • Frankel grading was grade A,B and C
  • Conservative treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tuberculosis, Spinal

Condition Hierarchy (Ancestors)

Tuberculosis, OsteoarticularTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBone Diseases, InfectiousBone DiseasesMusculoskeletal DiseasesSpondylitisSpinal Diseases

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
Principal Investigator

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 23, 2015

Study Start

January 1, 2009

Primary Completion

February 1, 2014

Study Completion

September 1, 2015

Last Updated

December 23, 2015

Record last verified: 2015-12