Ipsilateral Neck and Shaft Fractures and Internal Fixation Method and Follow Up At One Year Postoperative for Radiological and Functional OutcomesNCT06826521
Radiological and Functional Outcomes of Internal Fixation Methods for Ipsilateral Femoral Neck and Shaft Fractures in Young Adult Patients
An observational study of Ipsilateral Neck and Shaft Fractures and Internal Fixation Method and Follow Up At One Year Postoperative for Radiological and Functional Outcomes, run by Assiut University at 1 site in Egypt.
Trial summary
Does the single construct produce more favourable radiological and functional outcomes with less complication when it is compared to dual constructs for fixation of ipsilateral femoral neck and shaft fractures in young adult patients at one year follow up? Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ipsilateral Neck and Shaft Fractures and Internal Fixation Method and Follow Up At One Year Postoperative for Radiological and Functional Outcomes
- What is being tested?
- Single construct versus dual constructs will give satisfactory radiological and functional outcomes
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adult patients from 18- 55 years old not more than and not less Not with comrbodities like uncontrolled diabetes,renal disease and neurological deficits.
Who may be able to join
- Age of the patients from 18 to 55 years
- Recent fracture within one week
- Ipsilateral Neck and shaft femur fractures according to AO Classification including 31 B (all types of neck ) and 32 A,B and C ( all types of shaft femur )
Who cannot join
- Open fractures GIII
- patients more than 55 and less than 18 years old
- Patient with comorbidities: uncontrolled D.M, renal patient, neurological deficits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Does the single construct produce more favourable radiological and functional outcomes with less complication when it is compared to dual constructs for fixation of ipsilateral femoral neck and shaft fractures in young adult patients at one year follow up?
Read the detailed description
The investigators will do follow up for internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients at one year and observe does single construct will give favourable outcomes versus dual constructs?
- Being tested
- Single construct versus dual constructs will give satisfactory radiological and functional outcomes
- Keywords
- Radiological and functional outcomes of internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single construct versus dual constructs will give satisfactory radiological and functional outcomesProcedure or surgery
Single construct like cephalomedullary nail or long DHS in fixation of both neck and shaft fractures, dual constructs like DHS or cannulated screws and retrograde nail or DHS or cannulated screws and dymanic compression plate in fixation of both fractures.
| Study group | Role | What they receive |
|---|---|---|
| I will compare results with favourable outcomes between single and dual constructs | Not described Receives: Procedure: Single construct versus dual constructs will give satisfactory radiological and functional outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological union evaluation
Radiographic union evaluation of ipsilateral neck and shaft femur fractures after internal fixation methods at one year follow up in young adult patients using :
Radiographic union score of the hip for neck fracture Radiographic union score for the femur fracture. Minimum score for these scales is 10 and maximum is 30 High score means good outcome
Measured: Assessment of radiological union and the time will be taken at one year follow up
Secondary outcomes (2)
Functional outcome
Functional outcome will be assessed after internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients using friedman and wyman scale to assess whether patients have pain , Impaired daily life activities and loss of hip and knee range of motion . this scale is categorised by good, fair and poor outcome Good which have no pain no impaired daily life activities and less than 20 % loss of hip and knee range of motion Fair mild impaired daily life activities, mild to moderate pain and 20_50% loss of hip and knee range of motion Poor moderate impaired daily life activities, severe pain and more than 50% loss of hip and knee range of motion.
Measured: One year follow up
Complications
Complications will be reported if occured like non- union, infection and avascular necrosis of the neck.
Measured: One year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ipsilateral Neck and Shaft Fractures and Internal Fixation Method and Follow Up At One Year Postoperative for Radiological and Functional OutcomesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Ibrahim khalifa yakoup, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826521
- Sponsor's protocol ID
- RFOIFMIFNSFYAP
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological and Functional Outcomes of Internal Fixation Methods for Ipsilateral Femoral Neck and Shaft Fractures in Young Adult Patients
- ClinicalTrials.gov ID
- NCT06826521
- Acronym / sponsor ID
- RFOIFMIFNSFYAP
- Keywords
- Radiological and functional outcomes of internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 14 Feb 2025 (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.
Does the single construct produce more favourable radiological and functional outcomes with less complication when it is compared to dual constructs for fixation of ipsilateral femoral neck and shaft fractures in young adult patients at one year follow up?
Detailed description
The investigators will do follow up for internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients at one year and observe does single construct will give favourable outcomes versus dual constructs?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I will compare results with favourable outcomes between single and dual constructs | – | Procedure: Single construct versus dual constructs will give satisfactory radiological and functional outcomes |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adult patients from 18- 55 years old not more than and not less Not with comrbodities like uncontrolled diabetes,renal disease and neurological deficits.
Key inclusion criteria (3 listed)
- Age of the patients from 18 to 55 years
- Recent fracture within one week
- Ipsilateral Neck and shaft femur fractures according to AO Classification including 31 B (all types of neck ) and 32 A,B and C ( all types of shaft femur )
Key exclusion criteria (3 listed)
- Open fractures GIII
- patients more than 55 and less than 18 years old
- Patient with comorbidities: uncontrolled D.M, renal patient, neurological deficits.
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 |
|---|---|---|
| Single construct versus dual constructs will give satisfactory radiological and functional outcomesSingle construct like cephalomedullary nail or long DHS in fixation of both neck and shaft fractures, dual constructs like DHS or cannulated screws and retrograde nail or DHS or cannulated screws and dymanic compression plate in fixation of both fractures. | Procedure or surgery | I will compare results with favourable outcomes between single and dual constructs |
Primary outcome
Radiological union evaluation
Time frame: Assessment of radiological union and the time will be taken at one year follow up
Radiographic union evaluation of ipsilateral neck and shaft femur fractures after internal fixation methods at one year follow up in young adult patients using : Radiographic union score of the hip for neck fracture Radiographic union score for the femur fracture. Minimum score for these scales is 10 and maximum is 30 High score means good outcome
2 secondary outcomes
Functional outcome
Time frame: One year follow up
Complications
Time frame: One year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
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 Ipsilateral Neck and Shaft Fractures and Internal Fixation Method and Follow Up At One Year Postoperative for Radiological and Functional Outcomes, run by Assiut 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abanoub Ibrahim Khalifa yakoup, Resident doctor (+201272105193, abanoubibrahim233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological union evaluation (time frame: Assessment of radiological union and the time will be taken at one year follow up). 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 Feb 2025.