Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck
Istituto Ortopedico Rizzoli
100 participants
Nov 23, 2020
OBSERVATIONAL
Conditions
Summary
The study aims to assess the adequacy of a set of clinical and laboratory investigations for identifying the osteosarcopenia status in patients undergoing a hip replacement for a fragility fracture of the femoral neck. The control group will consist of patients undergoing a hip replacement for osteoarthritis, as the decrease in muscle function and bone quality is less severe in this condition than in osteoporosis.
Eligibility
Inclusion Criteria2
- Patients who came to observation with femoral neck fracture of possible osteoporotic nature (no or minimal trauma) to be treated with endoprosthesis or hip arthroplasty.
- Competent patients who have signed consent to participate in the study (see Informed Consent section of this protocol).
Exclusion Criteria9
- Previous osteoporotic fractures
- Previous prosthetic surgery for orthopedic diseases
- Pre-existing clinical conditions that led to permanent immobility
- Neoplastic diseases
- Autoimmune diseases
- Severe myopathies
- Chronic viral infections (HBV, HCV, HIV);
- Chronic treatment with anti-osteoporotic drugs, immunosuppressive drugs, and insulin
- Paget's disease
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Interventions
Assessment of muscle performance based on self-reported information about grip strength, assistance with walking, rising from a chair, climbing stairs, and falls.
Assessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.
Assessment of histomorphology and ultrastructure of muscle biopsies taken from the upper portion of the vastus lateralis muscle, which is accessed in the surgical procedure of hip replacement.
Quantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.
Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.
Assessment of dietary habits based on self-reported information about the monthly- weekly- or daily-frequency consumption of main food groups, including cereals and bread, meat, fish, fruit, vegetable, legumes, dairy products, sweets and snacks, drinks, and dietary supplements.
Assessment of gut microbiome composition on stool samples.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04730622