Hip AbnormalitiesNSANCT04846465
Femoral Neck-shaft Angle in Sohag Population
An observational study of Hip Abnormalities and Femur; Angulation, run by Sohag University at 1 site in Egypt.
Trial summary
The femur or thigh bone is the strongest and longest bone of the body and about 45 cm long in an average man that means approximately one fourth of the height of individual. It has upper end, lower end and a cylindrical shaft. Upper end consists of head, neck. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Abnormalities, Femur; Angulation, Urinary Stone
- What is being tested?
- Screening in picture archiving and communication system (PACS) .
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Sep 2021to 1 Nov 2021
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants who underwent computed tomography (CT) of the femur and acetabulum in departments of Radiology in Sohag University Hospital
Who may be able to join
- Adults, eligible and adequate imaging data for measurement, and absence of fracture, arthritis, tumor, deformity, or surgery on the proximal part of the femur or any disorder that may affect measurements of femoral neck-shaft angle
Who cannot join
- Adults with incomplete imaging data; and fracture, arthritis, tumor, deformity, or surgery on the proximal part of the femur
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Salwa M Ouies, Assistant professor, 01002073124
About this study
Official title: Femoral Neck-shaft Angle in Sohag Population: Variation Relating to Age and Sex.
The femur or thigh bone is the strongest and longest bone of the body and about 45 cm long in an average man that means approximately one fourth of the height of individual. It has upper end, lower end and a cylindrical shaft. Upper end consists of head, neck. The neck is about 5 cm long, connects the head to the shaft and is directed upward, medially and slightly forward and making an angle about 125 with shaft but the angle is wider in children. The neck-shaft angle (NSA ) is defined as the angle formed by the neck axis and long axis of the shaft of femur.The knowledge of the neck shaft angle is valuable in the diagnosis and treatment of fracture of upper end of femur.
The aim of the study is :
- to evaluate the normal values of femoral neck-shaft angle
- to detect factors that may affect this angle as age, and sex, in Egyptian adults from Sohag.
- Being tested
- Screening in picture archiving and communication system (PACS) .
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening in picture archiving and communication system (PACS) .Other
Screening in picture archiving and communication system (PACS) , the images of the participants who underwent computed tomography (CT) of the femur and acetabulum.
| Study group | Role | What they receive |
|---|---|---|
| male | normal Sohag healthy male (≥18 \& ≤ 60 years) Receives: Other: Screening in picture archiving and communication system (PACS) . | |
| female | normal Sohag healthy female (≥18 \& ≤ 60 years) Receives: Other: Screening in picture archiving and communication system (PACS) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure femoral neck-shaft angle ( NSA) .
We will use Computed Tomography (CT) in determination and measurement of femoral neck shaft angle ( NSA) and its variation relating to age and sex.
Neck-shaft angle will be measured using Image Works by noting angle between two intersection lines representing proximal femoral shaft axis and the femoral neck axis.
Normal neck-shaft angle varies from 115°-140° (mean of 126°). Normal range neck shaft angle is 121°-138°in male. Normal range neck shaft angle is 119°-137°in female.
Measured: 16 weeks following the startpoint of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start14 Sep 2021 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Talaat Bushra, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846465
- Sponsor's protocol ID
- Soh-Med-21-04-05
- Acronym
- NSA
- Status last verified
- Sep 2021
- First submitted
- 14 Apr 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Neck-shaft Angle in Sohag Population: Variation Relating to Age and Sex.
- ClinicalTrials.gov ID
- NCT04846465
- Acronym / sponsor ID
- NSA / Soh-Med-21-04-05
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Sep 2021 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 15 Apr 2021 (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.
The femur or thigh bone is the strongest and longest bone of the body and about 45 cm long in an average man that means approximately one fourth of the height of individual. It has upper end, lower end and a cylindrical shaft. Upper end consists of head, neck. The neck is about 5 cm long, connects the head to the shaft and is directed upward, medially and slightly forward and making an angle about 125 with shaft but the angle is wider in children. The neck-shaft angle (NSA ) is defined as the angle formed by the neck axis and long axis of the shaft of femur.The knowledge of the neck shaft angle is valuable in the diagnosis and treatment of fracture of upper end of femur.
The aim of the study is :
- to evaluate the normal values of femoral neck-shaft angle
- to detect factors that may affect this angle as age, and sex, in Egyptian adults from Sohag.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male | – | Other: Screening in picture archiving and communication system (PACS) .normal Sohag healthy male (≥18 \& ≤ 60 years) |
| female | – | Other: Screening in picture archiving and communication system (PACS) .normal Sohag healthy female (≥18 \& ≤ 60 years) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants who underwent computed tomography (CT) of the femur and acetabulum in departments of Radiology in Sohag University Hospital
Key inclusion criteria (1 listed)
- Adults, eligible and adequate imaging data for measurement, and absence of fracture, arthritis, tumor, deformity, or surgery on the proximal part of the femur or any disorder that may affect measurements of femoral neck-shaft angle
Key exclusion criteria (1 listed)
- Adults with incomplete imaging data; and fracture, arthritis, tumor, deformity, or surgery on the proximal part of the femur
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 |
|---|---|---|
| Screening in picture archiving and communication system (PACS) .Screening in picture archiving and communication system (PACS) , the images of the participants who underwent computed tomography (CT) of the femur and acetabulum. | Other | female, male |
Primary outcome
To measure femoral neck-shaft angle ( NSA) .
Time frame: 16 weeks following the startpoint of the study
We will use Computed Tomography (CT) in determination and measurement of femoral neck shaft angle ( NSA) and its variation relating to age and sex. Neck-shaft angle will be measured using Image Works by noting angle between two intersection lines representing proximal femoral shaft axis and the femoral neck axis. Normal neck-shaft angle varies from 115°-140° (mean of 126°). Normal range neck shaft angle is 121°-138°in male. Normal range neck shaft angle is 119°-137°in female.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
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 Hip Abnormalities and Femur; Angulation, run by Sohag 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 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Talaat Bushra, demonstrator (01281040678 ext. +20, marena011140@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure femoral neck-shaft angle ( NSA) . (time frame: 16 weeks following the startpoint of the study). 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 16 Sep 2021.