Nutritional Status and Its Modifications After Hip Replacement

Frail Elderly Syndrome Clinical Trial

Official title:

Prognostic Potential of the Preoperative Nutritional Status and Its Postoperative Variation in Patients Undergoing Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981354
• Other study ID #: NUTRIANCA (PI: M Briguglio)
• Secondary ID: L4133
• Status: Completed
• Start date: May 31, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.

Description:

Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. Patients undergoing hip surgery would be enrolled before the surgical operation and would be evaluated three times: preoperative, postoperative, and after discharge. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• caucasian

• arthroplasty intervention program with hip prosthesis placement

• signature and acceptance of informed consent to collaborate in all the procedures necessary for the study

Exclusion Criteria:

• heart failure stage III-IV

• renal failure stage III-IV

• actual cancer

• past neurological disorders (including, but not limited to cerebral ischemia, cerebral haemorrhages, brain tumors, endocranial aneurysms)

• neurodegenerative disorders (including, but not limited to Alzheimer's dementia, fronto-temporal dementia)

• actual major psychopharmacological therapies

• pregnancy certified by self-declaration

• inability to adhere to the rehabilitation protocol or to carry out the controls

• non-acceptance of informed consent

• revision interventions

• previously established and documented sleep disorders

• shift or part-time worker

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Hip Arthropathy
• Malnutrition
• Malnutrition; Anemia

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline level of hemoglobin at 14 days after surgical operation	One of the main decision-making factors that guide the clinician to discharge the patient is the hemoglobin level. The association between preoperative hemoglobin and hemoglobin at discharge was already observed in past orthopedic cohorts, with a loss of 3.3 g/dl being considered clinically relevant. Patients with a better nutritional status may have a reduced fall in hemoglobin after the surgical operation.	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline level of pre-albumin at 14 days after surgical operation	Pre-albumin (mg/dl)	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline level of total lymphocyte count at 14 days after surgical operation	Total lymphocyte count (cells/mm^3)	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline level of iron at 14 days after surgical operation	Iron (µg/dl)	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline level of vitamin D at 14 days after surgical operation	25[OH]D (ng/ml)	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline of weight 14 days after surgical operation	Weight (kg)	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline of calf circumference 14 days after surgical operation	Calf circumference (cm)	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline of % of fat mass at 14 days after surgical operation	Bioelectrical impedance analysis (% of fat mass and % of lean mass)	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline of hand-grip strength at 14 days after surgical operation	Hand-grip strength (kg). For this test, the higher values, the better is.	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline of FIM test at 14 days after surgical operation	Functional Independence Measure (FIM) (18-126 point scale). For this test, the higher values, the better is.	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline of 10 meter walking test at 14 days after surgical operation	10 meter walking test (m/s). For this test, the higher values, the better is.	Before the surgical operation, after 3 days, after 14 days.
Secondary	Change from baseline of POMA at 14 days after surgical operation	Performance Oriented Mobility Assessment (POMA) (0-32 point scale). For this test, the higher values, the better is.	Before the surgical operation, after 3 days, after 14 days.