ThoracolumbarNCT04597567
Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures
A study testing Metal removal in people with Thoracolumbar, run by Assiut University.
Trial summary
Comparing clinical outcome between patients who underwent metal removal and those who retained the metal Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracolumbar
- What is being tested?
- Metal removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-60 years
- Posterior fixation
- Six to nine months after fixation
- Neurologically free patient
- Fracture consolidation detected by ct
- Types A3\&A4 fractures
Who cannot join
- unstable fractures B\&C
- pathological fractures
- multilevel fractures
- poly trauma patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Spine Fractures
Comparing clinical outcome between patients who underwent metal removal and those who retained the metal
- Conditions
- Thoracolumbar
- Being tested
- Metal removal
- Keywords
- Metal removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal removalProcedure or surgery
Implant removal after fracture consolidation after posterior fixation of thoracolumbar spine fractures
| Study group | Role | What they receive |
|---|---|---|
| Metal removal | Active comparator | Not described Receives: Procedure: Metal removal |
| Metal retention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-5L questionnaire
Measuring the quality of life after metal removal
Measured: Baseline
Secondary outcomes (1)
Oswestry disability index
Measuring the quality of life after metal removal or without removal
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThoracolumbarStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samir Mondy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597567
- Sponsor's protocol ID
- Metal removal
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16814787
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Spine Fractures
- ClinicalTrials.gov ID
- NCT04597567
- Acronym / sponsor ID
- Metal removal
- Conditions
- Thoracolumbar
- Keywords
- Metal removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing clinical outcome between patients who underwent metal removal and those who retained the metal
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal removal | Active comparator | Procedure: Metal removal |
| Metal retention | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age 18-60 years
- Posterior fixation
- Six to nine months after fixation
- Neurologically free patient
- Fracture consolidation detected by ct
Key exclusion criteria (4 listed)
- unstable fractures B\&C
- pathological fractures
- multilevel fractures
- poly trauma patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metal removalImplant removal after fracture consolidation after posterior fixation of thoracolumbar spine fractures | Procedure or surgery | Metal removal |
Primary outcome
EQ-5D-5L questionnaire
Time frame: Baseline
Measuring the quality of life after metal removal
1 secondary outcome
Oswestry disability index
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 16814787Court-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Metal removal in people with Thoracolumbar, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Samir, Physician (01125098684, mahmoudsamir9463@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D-5L questionnaire (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04597567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.