Nutritional Status and Its Modifications After Hip Replacement

NCT03981354 | Completed

• 2 other identifiers: NUTRIANCA (PI: M Briguglio)L4133
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Arthropathy; Malnutrition; Anemia; Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  Before the surgical operation, after 3 days, after 14 days.

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

  Before the surgical operation, after 3 days, after 14 days.

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

  Before the surgical operation, after 3 days, after 14 days.

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

  Before the surgical operation, after 3 days, after 14 days.

• Change from baseline of weight 14 days after surgical operation

  Before the surgical operation, after 3 days, after 14 days.

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

You may qualify if:

• caucasian
• arthroplasty intervention program with hip prosthesis placement
• signature and acceptance of informed consent to collaborate in all the procedures necessary for the study

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Location

MeSH Terms

Conditions

Malnutrition; Anemia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Matteo Briguglio

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 10, 2019
• Study Start: May 31, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

IT (1)