Nutritional Status and Its Modifications After Hip Replacement

NCT ID: NCT03981354

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-31

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Arthropathy Malnutrition; Anemia Frail Elderly Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matteo Briguglio

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

L4133

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NUTRIANCA (PI: M Briguglio)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Immunonutrition in Total Hip Arthroplasty
NCT02580214 COMPLETED PHASE2/PHASE3