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Hip FractureNCT07443046

Regional Muscle Balance and Hip Fracture Patterns

An observational study of Hip Fracture and Sarcopenia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hip Fracture, Sarcopenia, Muscle
How many people
79 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2024to 1 Jul 2025
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Older adults aged 60 years and older presenting with hip fractures after low-energy falls were prospectively enrolled. Participants were evaluated in a tertiary care orthopedic trauma center, and fracture types were classified as femoral neck fracture or intertrochanteric femur fracture. All participants underwent standardized clinical assessment and CT-based muscle measurements at admission.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Bilkent City Hospital

    Ankara, Çankaya, 06800

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Keywords
Regional Muscle Balance, Gluteus Medius, Psoas Muscle, CT-Based Muscle Measurement, Hip Fracture Pattern, Geriatric Fracture, Musculoskeletal Biomechanics
Medical subject headings
Hip Fractures, Sarcopenia, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07443046
Study groupRoleWhat they receive
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.
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hip Fracture Pattern

    Fracture configuration classified based on radiographic evaluation at hospital admission.

    Measured: Baseline (at admission)

Secondary outcomes (8)

  1. Gluteus-to-Psoas Ratio

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

    Measured: Baseline

  2. Total Psoas Muscle Area

    Cross-sectional area measured on CT at L3 level.

    Measured: Baseline

  3. Gluteus Medius Muscle Area

    Cross-sectional area measured at inferior sacroiliac joint level.

    Measured: Baseline

  4. Appendicular Skeletal Muscle Mass Index (ASMI)

    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)

    Measured: Baseline

  5. Psoas Muscle Index (PMI)

    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)

    Measured: Baseline

  6. Geriatric Nutritional Risk Index (GNRI)

    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)

    Measured: Baseline

  7. Charlson Comorbidity Index (CCI)

    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

    Measured: Baseline

  8. Socioeconomic Status (Income Level and Residence)

    Income category and residence classification (urban/rural).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start1 Jul 2024
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

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
Prospective
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07443046
Sponsor's protocol ID
TABED 2-24-273
Status last verified
Feb 2026
First submitted
25 Feb 2026
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37208980

  • 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.

    PubMed 38470134

  • 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.

    PubMed 31997667

  • 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.

    PubMed 39956950

  • 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.

    PubMed 35658691

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fracture and Sarcopenia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

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 4 inclusion and 8 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 3 Mar 2026. 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 Turkey (Türkiye). 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?

Hip Fracture Pattern (time frame: Baseline (at admission)). 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 NCT07443046, which also lists 5 linked publications.

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 3 Mar 2026.

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