Skip to main content
OpenTrials
Completed

NCT Number: NCT03981354

Nutritional Status and Its Modifications After Hip Replacement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Arthropathy Anemia Frail Elderly Syndrome Hematologic Diseases Hemic and Lymphatic Diseases Malnutrition Malnutrition; Anemia Nutrition Disorders Nutritional and Metabolic Diseases

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Change from baseline level of hemoglobin at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    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.

Secondary outcomes

  1. Change from baseline level of pre-albumin at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Pre-albumin (mg/dl)

  2. Change from baseline level of total lymphocyte count at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Total lymphocyte count (cells/mm^3)

  3. Change from baseline level of iron at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Iron (μg/dl)

  4. Change from baseline level of vitamin D at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    25[OH]D (ng/ml)

  5. Change from baseline of weight 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Weight (kg)

  6. Change from baseline of calf circumference 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Calf circumference (cm)

  7. Change from baseline of % of fat mass at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Bioelectrical impedance analysis (% of fat mass and % of lean mass)

  8. Change from baseline of hand-grip strength at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Hand-grip strength (kg). For this test, the higher values, the better is.

  9. Change from baseline of FIM test at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Functional Independence Measure (FIM) (18-126 point scale). For this test, the higher values, the better is.

  10. Change from baseline of 10 meter walking test at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    10 meter walking test (m/s). For this test, the higher values, the better is.

  11. Change from baseline of POMA at 14 days after surgical operation

    Time frame: Before the surgical operation, after 3 days, after 14 days.

    Performance Oriented Mobility Assessment (POMA) (0-32 point scale). For this test, the higher values, the better is.

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2019
Registry last updated
May 11, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.