Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
Comparing clinical outcome between patients who underwent metal removal and those who retained the metal
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2020
CompletedFirst Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2022
CompletedOctober 22, 2020
October 1, 2020
2 years
October 16, 2020
October 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EQ-5D-5L questionnaire
Measuring the quality of life after metal removal
Baseline
Secondary Outcomes (1)
Oswestry disability index
Baseline
Study Arms (2)
Metal removal
ACTIVE COMPARATORMetal retention
NO INTERVENTIONInterventions
Implant removal after fracture consolidation after posterior fixation of thoracolumbar spine fractures
Eligibility Criteria
You may qualify if:
- age 18-60 years
- Posterior fixation
- Six to nine months after fixation
- Neurologically free patient
- Fracture consolidation detected by ct
- Types A3\&A4 fractures
You may not qualify if:
- unstable fractures B\&C
- pathological fractures
- multilevel fractures
- poly trauma patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
PMID: 16814787BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
October 15, 2020
Primary Completion
October 15, 2022
Study Completion
November 15, 2022
Last Updated
October 22, 2020
Record last verified: 2020-10