Clinical trial NCT03981354: Nutritional Status and Its Modifications After Hip Replacement
Official title: Prognostic Potential of the Preoperative Nutritional Status and Its Postoperative Variation in Patients Undergoing Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Arthropathy
Malnutrition; Anemia
Frail Elderly Syndrome
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline level of hemoglobin at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
Secondary outcomes:
measure: Change from baseline level of pre-albumin at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline level of total lymphocyte count at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline level of iron at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline level of vitamin D at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline of weight 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline of calf circumference 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline of % of fat mass at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline of hand-grip strength at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline of FIM test at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline of 10 meter walking test at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
measure: Change from baseline of POMA at 14 days after surgical operation
timeFrame: Before the surgical operation, after 3 days, after 14 days.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Matteo Briguglio
role: PRINCIPAL_INVESTIGATOR
References: