NCT07196982

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

September 20, 2025

Last Update Submit

September 20, 2025

Conditions

Keywords

Intertrochanteric FracturesFemoral Lateral Wall FracturesBone Mineral Density

Outcome Measures

Primary Outcomes (1)

  • 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.

    From hospital admission to postoperative BMD assessment (within 3 months of injury)

Study Arms (2)

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.

Other: No intervention (observational study)

Interventions

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.

Intertrochanteric Fracture with Lateral Wall Involvement

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The medical record system and imaging system of the Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 252000, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hip Fractures

Interventions

Observation

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2025

First Posted

September 29, 2025

Study Start

January 1, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations