Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures

Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Spine Fractures

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04597567

Enrollment

Registered

2020-10-22

Start date

2020-10-15

Completion date

2022-11-15

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracolumbar

Keywords

Metal removal

Brief summary

Comparing clinical outcome between patients who underwent metal removal and those who retained the metal

Interventions

PROCEDUREMetal removal

Implant removal after fracture consolidation after posterior fixation of thoracolumbar spine fractures

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* age 18-60 years * Posterior fixation * Six to nine months after fixation * Neurologically free patient * Fracture consolidation detected by ct * Types A3&A4 fractures

Exclusion criteria

* unstable fractures B&C * pathological fractures * multilevel fractures * poly trauma patients

Design outcomes

Primary

Measure	Time frame	Description
EQ-5D-5L questionnaire	Baseline	Measuring the quality of life after metal removal

Secondary

Measure	Time frame	Description
Oswestry disability index	Baseline	Measuring the quality of life after metal removal or without removal

Contacts

Primary ContactMahmoud Samir, Physician

mahmoudsamir9463@gmail.com01125098684

Backup ContactMahmoud Fouad, Phd

Dr.m.fouad@gmail.com0114227270

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026