Intertrochanteric Femoral FractureFractureNCT07196982
Risk Factors for Intertrochanteric Femoral Fractures With Concomitant Lateral Wall Involvement in Elderly Women
An observational study of Intertrochanteric Femoral Fracture, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study aims to better understand the factors that increase the risk of a special type of hip fracture in older women, known as intertrochanteric femoral fractures with lateral wall involvement. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Intertrochanteric Femoral Fracture
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 28 Feb 2024
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population consisted of postmenopausal women admitted to the Department of Orthopedics at the Second Affiliated Hospital of Soochow University between January 2023 and February 2024 with a diagnosis of intertrochanteric femoral fracture. A total of 49 patients were included after applying eligibility criteria. Of these, 29 had isolated intertrochanteric fractures and 20 had intertrochanteric fractures with concomitant lateral wall involvement. All patients underwent surgical fixation with proximal femoral nail antirotation (PFNA), with or without additional lateral wall plate fixation, according to clinical indications.
Who may be able to join
- Postmenopausal women diagnosed with intertrochanteric femoral fractures.
- History of low-energy trauma (e.g., fall from standing height).
- Treated surgically with proximal femoral nail antirotation (PFNA) device, with or without lateral wall plate fixation.
- Availability of complete demographic and clinical data (age, height, weight, bone mineral density, and bone turnover markers).
- Eligible for retrospective case-control analysis.
Who cannot join
- High-energy trauma (e.g., motor vehicle accidents).
- Severe systemic comorbidities such as hepatic or renal failure, bone tumors, or endocrine disorders (e.g., hyperparathyroidism).
- Use of medications affecting bone metabolism within 6 months before surgery.
- Diagnosis of diabetes mellitus.
- History of chronic smoking or alcohol abuse.
- Inability to provide accurate anthropometric data (height and weight).
Trial locations and contacts
1 site in 1 country.
China1 site
The medical record system and imaging system of the Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 252000
About this study
This study aims to better understand the factors that increase the risk of a special type of hip fracture in older women, known as intertrochanteric femoral fractures with lateral wall involvement. Hip fractures are very common in elderly patients, especially in women after menopause, and can seriously affect independence, mobility, and quality of life.
Between January 2023 and February 2024, postmenopausal women who were admitted with intertrochanteric femoral fractures were studied. Among them, some patients had fractures only in the main hip area, while others had additional involvement of the lateral wall, an important supportive structure of the hip. Researchers collected information such as age, body mass index (BMI), bone mineral density (BMD), and bone metabolism markers.
Read more
The study found that women with lower BMI and lower bone mineral density at the hip and lumbar spine were more likely to have lateral wall involvement in their fractures. Age and blood markers of bone metabolism did not show a strong link.
Understanding these risk factors can help doctors improve preoperative evaluation, choose better surgical strategies, and recommend preventive measures such as bone health management and fall prevention. This may ultimately reduce complications, improve recovery, and support better long-term outcomes for elderly women with hip fractures.
- Conditions
- Intertrochanteric Femoral Fracture
- Being tested
- No intervention (observational study)
- Keywords
- Intertrochanteric Fractures, Femoral Lateral Wall Fractures, Bone Mineral Density
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is an observational retrospective case-control study. No experimental intervention is administered. All participants received standard surgical management for intertrochanteric femoral fractures according to clinical practice, including proximal femoral nail antirotation (PFNA) with or without additional lateral wall plate fixation. The study only compares clinical and radiological data between patients with isolated intertrochanteric fractures and those with concomitant lateral wall involvement.
| Study group | Role | What they receive |
|---|---|---|
| Isolated Intertrochanteric Fracture | Postmenopausal women with intertrochanteric femoral fractures without lateral wall involvement. | |
| Intertrochanteric Fracture with Lateral Wall Involvement | Postmenopausal women with intertrochanteric femoral fractures with concomitant lateral wall involvement. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Bone Mineral Density, BMI, and Lateral Wall Involvement in Intertrochanteric Femoral Fractures
The primary outcome is to determine whether reduced bone mineral density (BMD) and lower body mass index (BMI) are independent risk factors for lateral wall involvement in elderly women with intertrochanteric femoral fractures. Measurements include lumbar spine and hip BMD assessed by dual-energy X-ray absorptiometry (DXA) and BMI calculated from height and weight. Logistic regression analysis is used to evaluate associations between these factors and the presence of lateral wall fractures.
Measured: From hospital admission to postoperative BMD assessment (within 3 months of injury)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Jan 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
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 Intertrochanteric Femoral FractureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196982
- Sponsor's protocol ID
- JD-HG-2025-107
- Acronym
- Fracture
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi G, Hu Z, Xie Z, Gu J, Lu Q, Ling Z. Risk factors for intertrochanteric femoral fractures with concomitant lateral wall involvement in elderly women. Front Surg. 2025 Dec 18;12:1730094. doi: 10.3389/fsurg.2025.1730094. eCollection 2025.
PubMed 41488883
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Intertrochanteric Femoral Fractures With Concomitant Lateral Wall Involvement in Elderly Women
- ClinicalTrials.gov ID
- NCT07196982
- Acronym / sponsor ID
- Fracture / JD-HG-2025-107
- Conditions
- Intertrochanteric Femoral Fracture
- Keywords
- Intertrochanteric Fractures, Femoral Lateral Wall Fractures, Bone Mineral Density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 29 Sep 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.
This study aims to better understand the factors that increase the risk of a special type of hip fracture in older women, known as intertrochanteric femoral fractures with lateral wall involvement. Hip fractures are very common in elderly patients, especially in women after menopause, and can seriously affect independence, mobility, and quality of life.
Between January 2023 and February 2024, postmenopausal women who were admitted with intertrochanteric femoral fractures were studied. Among them, some patients had fractures only in the main hip area, while others had additional involvement of the lateral wall, an important supportive structure of the hip. Researchers collected information such as age, body mass index (BMI), bone mineral density (BMD), and bone metabolism markers.
The study found that women with lower BMI and lower bone mineral density at the hip and lumbar spine were more likely to have lateral wall involvement in their fractures. Age and blood markers of bone metabolism did not show a strong link.
Understanding these risk factors can help doctors improve preoperative evaluation, choose better surgical strategies, and recommend preventive measures such as bone health management and fall prevention. This may ultimately reduce complications, improve recovery, and support better long-term outcomes for elderly women with hip fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated Intertrochanteric Fracture | – | –Postmenopausal women with intertrochanteric femoral fractures without lateral wall involvement. |
| Intertrochanteric Fracture with Lateral Wall Involvement | – | Other: No intervention (observational study)Postmenopausal women with intertrochanteric femoral fractures with concomitant lateral wall involvement. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consisted of postmenopausal women admitted to the Department of Orthopedics at the Second Affiliated Hospital of Soochow University between January 2023 and February 2024 with a diagnosis of intertrochanteric femoral fracture. A total of 49 patients were included after applying eligibility criteria. Of these, 29 had isolated intertrochanteric fractures and 20 had intertrochanteric fractures with concomitant lateral wall involvement. All patients underwent surgical fixation with proximal femoral nail antirotation (PFNA), with or without additional lateral wall plate fixation, according to clinical indications.
Key inclusion criteria (5 listed)
- Postmenopausal women diagnosed with intertrochanteric femoral fractures.
- History of low-energy trauma (e.g., fall from standing height).
- Treated surgically with proximal femoral nail antirotation (PFNA) device, with or without lateral wall plate fixation.
- Availability of complete demographic and clinical data (age, height, weight, bone mineral density, and bone turnover markers).
- Eligible for retrospective case-control analysis.
Key exclusion criteria (6 listed)
- High-energy trauma (e.g., motor vehicle accidents).
- Severe systemic comorbidities such as hepatic or renal failure, bone tumors, or endocrine disorders (e.g., hyperparathyroidism).
- Use of medications affecting bone metabolism within 6 months before surgery.
- Diagnosis of diabetes mellitus.
- History of chronic smoking or alcohol abuse.
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 |
|---|---|---|
| No intervention (observational study)This is an observational retrospective case-control study. No experimental intervention is administered. All participants received standard surgical management for intertrochanteric femoral fractures according to clinical practice, including proximal femoral nail antirotation (PFNA) with or without additional lateral wall plate fixation. The study only compares clinical and radiological data between patients with isolated intertrochanteric fractures and those with concomitant lateral wall involvement. | Other | Intertrochanteric Fracture with Lateral Wall Involvement |
Primary outcome
Association between Bone Mineral Density, BMI, and Lateral Wall Involvement in Intertrochanteric Femoral Fractures
Time frame: From hospital admission to postoperative BMD assessment (within 3 months of injury)
The primary outcome is to determine whether reduced bone mineral density (BMD) and lower body mass index (BMI) are independent risk factors for lateral wall involvement in elderly women with intertrochanteric femoral fractures. Measurements include lumbar spine and hip BMD assessed by dual-energy X-ray absorptiometry (DXA) and BMI calculated from height and weight. Logistic regression analysis is used to evaluate associations between these factors and the presence of lateral wall fractures.
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 29 Sep 2025.
- Derived from this study: PubMed 41488883Shi G, Hu Z, Xie Z, Gu J, Lu Q, Ling Z. Risk factors for intertrochanteric femoral fractures with concomitant lateral wall involvement in elderly women. Front Surg. 2025 Dec 18;12:1730094. doi: 10.3389/fsurg.2025.1730094. eCollection 2025.
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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.
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 Intertrochanteric Femoral Fracture, run by Second Affiliated Hospital of Soochow University at 1 site in China.
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 6 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 29 Sep 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 China. 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?
Association between Bone Mineral Density, BMI, and Lateral Wall Involvement in Intertrochanteric Femoral Fractures (time frame: From hospital admission to postoperative BMD assessment (within 3 months of injury)). 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 NCT07196982, 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 29 Sep 2025.