Hip ArthropathyNCT03981354
Nutritional Status and Its Modifications After Hip Replacement
An observational study of Hip Arthropathy and Malnutrition; Anemia, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Arthropathy, Malnutrition; Anemia, Frail Elderly Syndrome
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2019to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- caucasian
- arthroplasty intervention program with hip prosthesis placement
- signature and acceptance of informed consent to collaborate in all the procedures necessary for the study
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Potential of the Preoperative Nutritional Status and Its Postoperative Variation in Patients Undergoing Hip Arthroplasty
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.
Read the 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.
- Medical subject headings
- Malnutrition, Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pre-albumin (mg/dl)
Measured: Before the surgical operation, after 3 days, after 14 days.
Change from baseline level of total lymphocyte count at 14 days after surgical operation
Total lymphocyte count (cells/mm^3)
Measured: Before the surgical operation, after 3 days, after 14 days.
Change from baseline level of iron at 14 days after surgical operation
Iron (μg/dl)
Measured: Before the surgical operation, after 3 days, after 14 days.
Change from baseline level of vitamin D at 14 days after surgical operation
25[OH]D (ng/ml)
Measured: Before the surgical operation, after 3 days, after 14 days.
Change from baseline of weight 14 days after surgical operation
Weight (kg)
Measured: Before the surgical operation, after 3 days, after 14 days.
Change from baseline of calf circumference 14 days after surgical operation
Calf circumference (cm)
Measured: Before the surgical operation, after 3 days, after 14 days.
Change from baseline of % of fat mass at 14 days after surgical operation
Bioelectrical impedance analysis (% of fat mass and % of lean mass)
Measured: Before the surgical operation, after 3 days, after 14 days.
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.
Measured: Before the surgical operation, after 3 days, after 14 days.
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.
Measured: Before the surgical operation, after 3 days, after 14 days.
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.
Measured: Before the surgical operation, after 3 days, after 14 days.
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.
Measured: Before the surgical operation, after 3 days, after 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start31 May 2019
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Briguglio, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981354
- Sponsor's protocol ID
- NUTRIANCA (PI: M Briguglio)
- Other IDs
- L4133
- Status last verified
- May 2023
- First submitted
- 22 May 2019
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Potential of the Preoperative Nutritional Status and Its Postoperative Variation in Patients Undergoing Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03981354
- Acronym / sponsor ID
- NUTRIANCA (PI: M Briguglio)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- caucasian
- arthroplasty intervention program with hip prosthesis placement
- signature and acceptance of informed consent to collaborate in all the procedures necessary for the study
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
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.
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.
Change from baseline level of iron at 14 days after surgical operation
Time frame: Before the surgical operation, after 3 days, after 14 days.
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.
Change from baseline of weight 14 days after surgical operation
Time frame: Before the surgical operation, after 3 days, after 14 days.
Change from baseline of calf circumference 14 days after surgical operation
Time frame: Before the surgical operation, after 3 days, after 14 days.
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.
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.
Change from baseline of FIM test at 14 days after surgical operation
Time frame: Before the surgical operation, after 3 days, after 14 days.
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.
Change from baseline of POMA at 14 days after surgical operation
Time frame: Before the surgical operation, after 3 days, after 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Briguglio principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy and Malnutrition; Anemia, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline level of hemoglobin at 14 days after surgical operation (time frame: Before the surgical operation, after 3 days, after 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.