Comminuted Fracture TibiaFinite ElementNCT04388462
Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws) Choice Based on Finite Element Analysis Correlated With Clinical Outcome and Union.
An observational study of Comminuted Fracture Tibia, run by Cairo University at 1 site in Egypt.
Trial summary
study is to assess the clinical and radiological results of Comminuted fractures of the midshaft of the tibia; treated with interlocking nail +/- blocking screws or locked plating with predicted distribution of locking screws, choice based on finite element analysis correlated with clinical outcome and union. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Comminuted Fracture Tibia
- What is being tested?
- Finite element analysis
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2018to 2 May 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient with comminuted fractures of the midshaft of the tibia.
Who may be able to join
- patients with closed comminuted fractures of the midshaft of the tibia
- patients with age ranging from 25 to 45 years old
Who cannot join
- 1- Simple fractures of the midshaft of the tibia. 2- patients with open comminuted fractures of the midshaft of the tibia. 3- critical and ICU patients. 4- patients with ipsilateral lower limb fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Finite Element Analysis for Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws)
study is to assess the clinical and radiological results of Comminuted fractures of the midshaft of the tibia; treated with interlocking nail +/- blocking screws or locked plating with predicted distribution of locking screws, choice based on finite element analysis correlated with clinical outcome and union.
Read the detailed description
FE analyses will be performed using the finite element code COSMOS/M. The three-dimensional "lower leg" FE model (LL FE model) will be used included the tibia and the fibula. The bony structures will be generated by segmentation of a data set of computed tomographies from the Visible Human Project.
Analysis of data regarding clinical outcomes and radiological assessment of healing rate and union
- Conditions
- Comminuted Fracture Tibia
- Being tested
- Finite element analysis
- Keywords
- Comminuted fracture, Finite element analysis, Tibia
- Medical subject headings
- Fractures, Comminuted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finite element analysisOther
Biomechanical study to describe micromotion
| Study group | Role | What they receive |
|---|---|---|
| locked plating with predicted distribution of loc | Not described Receives: Other: Finite element analysis | |
| unlocked plating with predicted distribution of loc | Not described Receives: Other: Finite element analysis | |
| Interlocking nail +/- blocking screws | Not described Receives: Other: Finite element analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the fracture
radiographic evaluation of union rate and clinical outcomes
Measured: 3 month
Tibia Pain
Visual analogue scale
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start5 Jan 2018
- Primary completion1 Mar 2019
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comminuted Fracture TibiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Ahmed Abdalbary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388462
- Sponsor's protocol ID
- sahar Abdalbary
- Other IDs
- Ayman Ali Ali Saleh
- Acronym
- Finite Element
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data about the age and Phone to recall the patients. Data about Radiological investigation to be addressed by the finite element analysis
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finite Element Analysis for Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws)
- ClinicalTrials.gov ID
- NCT04388462
- Acronym / sponsor ID
- Finite Element / sahar Abdalbary
- Conditions
- Comminuted Fracture Tibia
- Keywords
- Comminuted fracture, Finite element analysis, Tibia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 14 May 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.
study is to assess the clinical and radiological results of Comminuted fractures of the midshaft of the tibia; treated with interlocking nail +/- blocking screws or locked plating with predicted distribution of locking screws, choice based on finite element analysis correlated with clinical outcome and union.
Detailed description
FE analyses will be performed using the finite element code COSMOS/M. The three-dimensional "lower leg" FE model (LL FE model) will be used included the tibia and the fibula. The bony structures will be generated by segmentation of a data set of computed tomographies from the Visible Human Project.
Analysis of data regarding clinical outcomes and radiological assessment of healing rate and union
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| locked plating with predicted distribution of loc | – | Other: Finite element analysis |
| unlocked plating with predicted distribution of loc | – | Other: Finite element analysis |
| Interlocking nail +/- blocking screws | – | Other: Finite element analysis |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient with comminuted fractures of the midshaft of the tibia.
Key inclusion criteria (2 listed)
- patients with closed comminuted fractures of the midshaft of the tibia
- patients with age ranging from 25 to 45 years old
Key exclusion criteria (1 listed)
- 1- Simple fractures of the midshaft of the tibia. 2- patients with open comminuted fractures of the midshaft of the tibia. 3- critical and ICU patients. 4- patients with ipsilateral lower limb fractures.
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 |
|---|---|---|
| Finite element analysisBiomechanical study to describe micromotion | Other | Interlocking nail +/- blocking screws, locked plating with predicted distribution of loc, unlocked plating with predicted distribution of loc |
Primary outcome
Healing of the fracture
Time frame: 3 month
radiographic evaluation of union rate and clinical outcomes
Tibia Pain
Time frame: 3 month
Visual analogue scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: Undecided. Data about the age and Phone to recall the patients. Data about Radiological investigation to be addressed by the finite element analysis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comminuted Fracture Tibia, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of the fracture (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2020.