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Completed

NCT Number: NCT07443046

Regional Muscle Balance and Hip Fracture Patterns

Hip fractures are common in older adults and are often associated with muscle loss and frailty. While many studies focus on overall muscle reduction (sarcopenia), the role of regional muscle balance around the hip remains unclear. This prospective observational study aims to evaluate whether differences in muscle distribution, particularly between the gluteus medius and psoas muscles measured using computed tomography (CT), are associated with different hip fracture patterns. The study also investigates the potential effects of socioeconomic status, nutritional risk, and comorbidity burden on fracture configuration. Understanding how regional muscle characteristics relate to hip fracture types may provide new insight into biomechanical mechanisms and support future prevention and rehabilitation strategies for older adults.

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Key information

Conditions

Hip Fracture Atrophy Femoral Fractures Fractures, Bone Frailty Hip Fractures Hip Injuries Leg Injuries Muscle Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hip Fracture Pattern

    Time frame: Baseline (at admission)

    Fracture configuration classified based on radiographic evaluation at hospital admission.

Secondary outcomes

  1. Gluteus-to-Psoas Ratio

    Time frame: Baseline

    CT-derived ratio of gluteus medius area to total psoas muscle area.

  2. Total Psoas Muscle Area

    Time frame: Baseline

    Cross-sectional area measured on CT at L3 level.

  3. Gluteus Medius Muscle Area

    Time frame: Baseline

    Cross-sectional area measured at inferior sacroiliac joint level.

  4. Appendicular Skeletal Muscle Mass Index (ASMI)

    Time frame: Baseline

    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)

  5. Psoas Muscle Index (PMI)

    Time frame: Baseline

    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)

  6. Geriatric Nutritional Risk Index (GNRI)

    Time frame: Baseline

    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)

  7. Charlson Comorbidity Index (CCI)

    Time frame: Baseline

    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

  8. Socioeconomic Status (Income Level and Residence)

    Time frame: Baseline

    Income category and residence classification (urban/rural).

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Regional Muscle Balance Rather Than Global Sarcopenia Is Associated With Hip Fracture Patterns: A Prospective CT-Based Comparative Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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