- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443046
Regional Muscle Balance and Hip Fracture Patterns
Regional Muscle Balance Rather Than Global Sarcopenia Is Associated With Hip Fracture Patterns: A Prospective CT-Based Comparative Study
Study Overview
Status
Conditions
Detailed Description
Hip fractures represent a major cause of morbidity and mortality in the aging population and are frequently associated with sarcopenia and frailty. Although previous studies have primarily focused on global muscle mass reduction, the biomechanical relevance of regional muscle distribution surrounding the hip joint has not been sufficiently investigated. This prospective observational study evaluates the association between regional muscle balance and hip fracture patterns in older adults using CT-based muscle measurements.
Participants aged 60 years and older presenting with hip fractures following low-energy falls were included. Demographic characteristics, socioeconomic status, nutritional risk assessed by the Geriatric Nutritional Risk Index (GNRI), and comorbidity burden measured by the Charlson Comorbidity Index were recorded. Cross-sectional muscle areas, including total skeletal muscle, bilateral psoas muscle, and gluteus medius muscle, were measured on standardized CT images. The gluteus-to-psoas ratio was calculated to assess regional muscle distribution.
The primary objective of the study is to determine whether CT-based regional muscle characteristics are associated with hip fracture configuration, specifically intertrochanteric and femoral neck fractures. Secondary objectives include evaluating the potential influence of nutritional and socioeconomic factors on fracture patterns. Findings from this study may improve understanding of hip fracture biomechanics and contribute to future risk stratification and individualized rehabilitation approaches.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥60 years
- Presentation with hip fracture following a low-energy fall
- Availability of pelvic computed tomography (CT) imaging at admission
- Ability to provide written informed consen
Exclusion Criteria:
- Pathological fractures
- Active malignancy
- Subtrochanteric fractures (≥5 cm distal to the lesser trochanter)
- High-energy trauma
- Neuromuscular disorders affecting muscle morphology
- Inflammatory systemic diseases
- Hemiparesis secondary to cerebrovascular events
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Femoral Neck Fracture (FNF)
Older adults (≥60 years) with hip fracture classified as femoral neck fracture after low-energy fall; CT-based muscle measurements and clinical variables were assessed.
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Intertrochanteric Femur Fracture (ITFF)
Older adults (≥60 years) with hip fracture classified as intertrochanteric femur fracture after low-energy fall; CT-based muscle measurements and clinical variables were assessed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hip Fracture Pattern
Time Frame: Baseline (at admission)
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Fracture configuration classified based on radiographic evaluation at hospital admission.
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Baseline (at admission)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gluteus-to-Psoas Ratio
Time Frame: Baseline
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CT-derived ratio of gluteus medius area to total psoas muscle area.
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Baseline
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Total Psoas Muscle Area
Time Frame: Baseline
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Cross-sectional area measured on CT at L3 level.
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Baseline
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Gluteus Medius Muscle Area
Time Frame: Baseline
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Cross-sectional area measured at inferior sacroiliac joint level.
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Baseline
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Socioeconomic Status (Income Level and Residence)
Time Frame: Baseline
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Income category and residence classification (urban/rural).
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Baseline
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Appendicular Skeletal Muscle Mass Index (ASMI)
Time Frame: Baseline
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Appendicular skeletal muscle mass index calculated from CT-based cross-sectional muscle area normalized to height squared (cm²/m²). Lower values indicate reduced skeletal muscle mass consistent with sarcopenia. There is no fixed theoretical maximum value; values depend on individual body composition. Higher values reflect greater muscle mass. Minimum: 0 Maximum: Not predefined (continuous variable) |
Baseline
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Psoas Muscle Index (PMI)
Time Frame: Baseline
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Height-adjusted psoas muscle cross-sectional area (cm²/m²) measured at the L3 vertebral level on CT imaging. Lower values indicate lower muscle mass and potential sarcopenia. Higher values reflect greater psoas muscle mass. Minimum: 0 Maximum: Not predefined (continuous variable) |
Baseline
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Geriatric Nutritional Risk Index (GNRI)
Time Frame: Baseline
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The Geriatric Nutritional Risk Index (GNRI) is a nutritional risk assessment score calculated using serum albumin levels and the ratio of actual to ideal body weight. Higher scores indicate better nutritional status, whereas lower scores indicate increased nutritional risk. Minimum: Theoretical minimum approximately 0 Maximum: Not predefined (typically >100 in well-nourished individuals) Higher score = better nutritional status Lower score = worse outcome (higher nutritional risk) |
Baseline
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Charlson Comorbidity Index (CCI)
Time Frame: Baseline
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The Charlson Comorbidity Index (CCI) is a weighted score used to predict mortality risk based on comorbid conditions. Age-adjusted CCI includes additional points based on age. Higher scores indicate greater comorbidity burden and higher predicted mortality risk. Minimum: 0 Maximum: Not fixed (depends on number of comorbidities) Higher score = worse health status Lower score = better health status |
Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Wang L, Yang M, Ge Y, Liu Y, Su Y, Guo Z, Huang P, Geng J, Wang G, Blake GM, He B, Yin L, Cheng X, Wu X, Engelke K, Vlug AG. Muscle size and density are independently associated with death after hip fracture: A prospective cohort study. J Cachexia Sarcopenia Muscle. 2023 Aug;14(4):1824-1835. doi: 10.1002/jcsm.13261. Epub 2023 May 19.
- Guven S, Naldoven OF, Alkan H, Erdogan Y, Cepni S, Veizi E. Laterally Protruded Cephalomedullary Nail Lag Screws are a Source of Consistent Thigh Pain After Pertrochanteric Fracture. J Orthop Trauma. 2024 Jun 1;38(6):320-326. doi: 10.1097/BOT.0000000000002803.
- Kim KH, Lee JH, Lim EJ. Weak psoas and spine extensors potentially predispose to hip fracture. Hip Int. 2021 May;31(3):430-434. doi: 10.1177/1120700020904337. Epub 2020 Jan 30.
- Veizi BGY, Imeri V, Naldoven OF, Guven S. Sarcopenia and sarcopenic obesity: Their association with postoperative outcomes in patients with hip fractures. J Hosp Med. 2025 Aug;20(8):816-823. doi: 10.1002/jhm.70007. Epub 2025 Feb 16.
- Yerli M, Yuce A, Ayaz MB, Bayraktar TO, Erkurt N, Dedeoglu SS, Imren Y, Gurbuz H. Effect of psoas and gluteus medius muscles attenuation on hip fracture type. Hip Int. 2023 Sep;33(5):952-957. doi: 10.1177/11207000221101169. Epub 2022 Jun 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Wounds and Injuries
- Pathologic Processes
- Pathological Conditions, Anatomical
- Leg Injuries
- Fractures, Bone
- Femoral Fractures
- Hip Injuries
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Frailty
- Hip Fractures
- Sarcopenia
Other Study ID Numbers
- TABED 2-24-273
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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