Femoral Shaft FractureNCT04195334
IMN Diameter to Femoral Canal Diameter and Union
A study testing internal fixation by IMN in people with Femoral Shaft Fracture, run by Assiut University.
Trial summary
To Detect the Relation Between the Intramedullary Nail Diameter to Canal Ratio and the Incidence of Non-union Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Femoral Shaft Fracture
- What is being tested?
- internal fixation by IMN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age (20_60) years old
- Closed fracture and open grade one
- Midshaft fractures type3\2 according to the OA classification
- pattern of the fracture (simple transverse,oblique ,spiral)
- Retrograde and Antigrade nail
Who cannot join
- Open fractures grade two and three.
- patient with comorbidities eg(DM.HTN…)
- severe osteoporosis with wide medulla .
- patient on regular steroid therapy.
- patient refused to be enrolled in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Intramedullary Nail Diameter to Canal Ratio Predict the Incidence of Femoral Nonunion?
To Detect the Relation Between the Intramedullary Nail Diameter to Canal Ratio and the Incidence of Non-union
Read the detailed description
Femoral intramedullary nail fixation is currently considered the ''gold standard'' for treatment of femoral shaft fractures in adult population. Clinical outcomes after operative treatment of proximal femur fracture have been shown to be dependent on achieving optimal mechanical alignment and union. Patient independent risk factors associated with nonunion after intramedullary fixation includes: open fracture, undreamed intramedullary nailing, fracture comminution, non-isthmal and particularly infra-isthma fracture location and infection. Patient dependent risk factors include smoking, diabetes, nonsteroidal anti-inflammatory medications, closed head injury and delayed weight. Unreamed nailing allows for better maintenance of the endosteal circulation at the expense of smaller diameter implants; in contrast, reamed applications permit a larger diameter nail, resulting in stronger fixation constructs and earlier fracture union. After reaming, a larger diameter intramedullary nail is placed. When initially reported, this treatment resulted in high success rates.
- Conditions
- Femoral Shaft Fracture
- Being tested
- internal fixation by IMN
- Keywords
- intramedullary nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal fixation by IMNDevice
using retrograde or antegrade IMN for femooral fractures fixation using a fit nail to the femoral intramedullary canaland follow up for union
| Study group | Role | What they receive |
|---|---|---|
| IMN and union | Experimental | putting an intramedullary nail in femoral shaft fractures and finding a relation between the nail diameter to femoral canal diameter and how this will affect healing or predict union Receives: Device: internal fixation by IMN |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio between IMN and femoral canal diameter and incidence of union objectively
We will measure union objectively using x ray (union in 3 or more cortices)
Measured: 6 months
measurement of union clinically
we will measure the union clinically using visual analog score after 6 weeks.( Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks).
then we will test if there is a relation between union and the ratio between femoral canal and IMN diameter.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Femoral Shaft FractureStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mina kamal, Assiut University
- Investigators
- ALY MOHAMADEEN, MD, Study chair, Assiut Universitymahmoud badran, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195334
- Sponsor's protocol ID
- IMN diameter and union
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Millar MJ, Wilkinson A, Navarre P, Steiner J, Vohora A, Hardidge A, Edwards E. Nail Fit: Does Nail Diameter to Canal Ratio Predict the Need for Exchange Nailing in the Setting of Aseptic, Hypertrophic Femoral Nonunions? J Orthop Trauma. 2018 May;32(5):245-250. doi: 10.1097/BOT.0000000000001110.
PubMed 29401087Shroeder JE, Mosheiff R, Khoury A, Liebergall M, Weil YA. The outcome of closed, intramedullary exchange nailing with reamed insertion in the treatment of femoral shaft nonunions. J Orthop Trauma. 2009 Oct;23(9):653-7. doi: 10.1097/BOT.0b013e3181a2a337.
PubMed 19897987Rudloff MI, Smith WR. Intramedullary nailing of the femur: current concepts concerning reaming. J Orthop Trauma. 2009 May-Jun;23(5 Suppl):S12-7. doi: 10.1097/BOT.0b013e31819f258a.
PubMed 19390369Collinge CA, Hymes R, Archdeacon M, Streubel P, Obremskey W, Weber T, Watson JT, Lowenberg D; Members of the Proximal Femur Working Group of the Southeast Trauma Consortium. Unstable Proximal Femur Fractures Treated With Proximal Femoral Locking Plates: A Retrospective, Multicenter Study of 111 Cases. J Orthop Trauma. 2016 Sep;30(9):489-95. doi: 10.1097/BOT.0000000000000602.
PubMed 27144821
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intramedullary Nail Diameter to Canal Ratio Predict the Incidence of Femoral Nonunion?
- ClinicalTrials.gov ID
- NCT04195334
- Acronym / sponsor ID
- IMN diameter and union
- Conditions
- Femoral Shaft Fracture
- Keywords
- intramedullary nail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Dec 2019 (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.
To Detect the Relation Between the Intramedullary Nail Diameter to Canal Ratio and the Incidence of Non-union
Detailed description
Femoral intramedullary nail fixation is currently considered the ''gold standard'' for treatment of femoral shaft fractures in adult population. Clinical outcomes after operative treatment of proximal femur fracture have been shown to be dependent on achieving optimal mechanical alignment and union. Patient independent risk factors associated with nonunion after intramedullary fixation includes: open fracture, undreamed intramedullary nailing, fracture comminution, non-isthmal and particularly infra-isthma fracture location and infection. Patient dependent risk factors include smoking, diabetes, nonsteroidal anti-inflammatory medications, closed head injury and delayed weight. Unreamed nailing allows for better maintenance of the endosteal circulation at the expense of smaller diameter implants; in contrast, reamed applications permit a larger diameter nail, resulting in stronger fixation constructs and earlier fracture union. After reaming, a larger diameter intramedullary nail is placed. When initially reported, this treatment resulted in high success rates.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMN and union | Experimental | Device: internal fixation by IMNputting an intramedullary nail in femoral shaft fractures and finding a relation between the nail diameter to femoral canal diameter and how this will affect healing or predict union |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age (20_60) years old
- Closed fracture and open grade one
- Midshaft fractures type3\2 according to the OA classification
- pattern of the fracture (simple transverse,oblique ,spiral)
- Retrograde and Antigrade nail
Key exclusion criteria (5 listed)
- Open fractures grade two and three.
- patient with comorbidities eg(DM.HTN…)
- severe osteoporosis with wide medulla .
- patient on regular steroid therapy.
- patient refused to be enrolled in the study
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 |
|---|---|---|
| internal fixation by IMNusing retrograde or antegrade IMN for femooral fractures fixation using a fit nail to the femoral intramedullary canaland follow up for union | Device | IMN and union |
Primary outcome
The ratio between IMN and femoral canal diameter and incidence of union objectively
Time frame: 6 months
We will measure union objectively using x ray (union in 3 or more cortices)
measurement of union clinically
Time frame: 6 months
we will measure the union clinically using visual analog score after 6 weeks.( Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks). then we will test if there is a relation between union and the ratio between femoral canal and IMN diameter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 29401087Millar MJ, Wilkinson A, Navarre P, Steiner J, Vohora A, Hardidge A, Edwards E. Nail Fit: Does Nail Diameter to Canal Ratio Predict the Need for Exchange Nailing in the Setting of Aseptic, Hypertrophic Femoral Nonunions? J Orthop Trauma. 2018 May;32(5):245-250. doi: 10.1097/BOT.0000000000001110.
- Background: PubMed 19897987Shroeder JE, Mosheiff R, Khoury A, Liebergall M, Weil YA. The outcome of closed, intramedullary exchange nailing with reamed insertion in the treatment of femoral shaft nonunions. J Orthop Trauma. 2009 Oct;23(9):653-7. doi: 10.1097/BOT.0b013e3181a2a337.
- Background: PubMed 19390369Rudloff MI, Smith WR. Intramedullary nailing of the femur: current concepts concerning reaming. J Orthop Trauma. 2009 May-Jun;23(5 Suppl):S12-7. doi: 10.1097/BOT.0b013e31819f258a.
- Background: PubMed 27144821Collinge CA, Hymes R, Archdeacon M, Streubel P, Obremskey W, Weber T, Watson JT, Lowenberg D; Members of the Proximal Femur Working Group of the Southeast Trauma Consortium. Unstable Proximal Femur Fractures Treated With Proximal Femoral Locking Plates: A Retrospective, Multicenter Study of 111 Cases. J Orthop Trauma. 2016 Sep;30(9):489-95. doi: 10.1097/BOT.0000000000000602.
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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.
ALY MOHAMADEEN, MD study chair
Assiut University
mahmoud badran, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing internal fixation by IMN in people with Femoral Shaft Fracture, 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 5 inclusion and 5 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 16 Sep 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 mina kamal, master (+201203380329, minakamalcr7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio between IMN and femoral canal diameter and incidence of union objectively (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT04195334, which also lists 4 linked publications.
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 16 Sep 2020.