Total Knee AnthroplastyORTHONUTRINCT07782502
Assessment of the Nutritional Status of Patients Undergoing Prosthetic Orthopedic Surgery: An Exploratory Study
A study testing Blood and physical performance tests in people with Total Knee Anthroplasty, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The aim of this study is to evaluate the impact of prosthetic orthopedic surgery on the nutritional status of patients undergoing total knee arthroplasty in adult patients scheduled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Anthroplasty
- What is being tested?
- Blood and physical performance tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years at the time of surgery
- Patients scheduled for total knee arthroplasty.
- Patients enrolled in the preoperative Enhanced Recovery After Surgery (ERAS) pathway.
- Patients affiliated with or covered by a social security system.
- French-speaking patients who have provided written informed consent
Who cannot join
- Patients scheduled for revision total knee arthroplasty
- Protected patients: adults under guardianship, curatorship, or other legal protection measures, or individuals deprived of liberty by judicial or administrative decision
- Patients hospitalized without consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to evaluate the impact of prosthetic orthopedic surgery on the nutritional status of patients undergoing total knee arthroplasty in adult patients scheduled.
This study is based on the hypothesis that prosthetic orthopedic surgery may induce or worsen malnutrition, an issue that has not been investigated to date.
Participants will perform an additionnal blood test, physical performance tests and questionnaires as part of this research.
Read the detailed description
Prosthetic joint surgery is now a major public health issue in France. According to data published by the French National Academy of Medicine, approximately 305,780 major joint arthroplasties were performed in 2017, representing a 39% increase over a ten-year period (219,826 procedures in 2006).
Malnutrition is common among patients undergoing major orthopedic surgery, with a reported prevalence of up to 50%, depending on the study population. Preoperative malnutrition has been associated with an increased risk of intraoperative events and postoperative complications.
Malnutrition is a modifiable biological risk factor. Optimizing nutritional status before total joint arthroplasty may improve the overall value of care while reducing the risk of intraoperative and postoperative complications.
A composite index combining serum albumin concentration and total lymphocyte count, the Prognostic Nutritional Index (PNI), has been developed to assess nutritional status. Among patients undergoing total knee arthroplasty, better perioperative nutritional status has been associated with improved clinical and functional outcomes, including reduced pain, better patient-reported outcome measures (PROMs), and improved knee biomechanics. These benefits have been shown to persist for more than one year after surgery. If many studies focus on the patient's nutritional status prior to surgery, very few have examined the impact of surgery on post-operative nutritional outcomes.
- Conditions
- Total Knee Anthroplasty
- Being tested
- Blood and physical performance tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and physical performance testsDiagnostic test
Additional postoperative blood tests. Physical performance test (hand grip-test, measurement of the calf circumference of the non-operated leg, walking test, chair stand test and Timed Up \& Go test.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroscopy | Experimental | Total knee arthroscopy Receives: Diagnostic Test: Blood and physical performance tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients nutritional status
The primary outcome measure is the prevalence of patients with a low Prognostic Nutritional Index (PNI) (PNI < 40).
PNI value ≥ 50: Normal; PNI value < 50: Mild malnutrition; PNI value< 45: Moderate to severe malnutrition; PNI value< 40: Serious malnutrition.
Measured: At baseline and 1 month follow-up.
Secondary outcomes (15)
Change from Baseline in Prognostic Nutritional Index (PNI) at 1 Month
Measured with Prognostic Nutritional Index (PNI), PNI value ≥ 50: Normal; PNI value < 50: Mild malnutrition; PNI value< 45: Moderate to severe malnutrition; PNI value< 40: Serious malnutrition.
Measured: At baseline and 1 month follow-up
Change in biologicals parameters
Changes in biological parameters, including complete blood count (CBC).
Measured: At baseline and 1 month follow-up
Change in biologicals parameters (ionogram)
Changes in biological parameters, including Ionogram (sodium, potassium, chlorides, bicarbonates , unit : mmol/L)
Measured: At baseline and 1 month follow-up
Change in biologicals parameters
Changes in biological parameters, including serum albumin
Measured: At baseline and 1 month follow-up
Change in biologicals parameters
Changes in biological parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST)
Measured: At baseline and 1 month follow-up
Change in biologicals parameters
Changes in biological parameters, serum creatinine, C-reactive protein (CRP), and Creatine phosphokinase (CPK)
Measured: At baseline and 1 month follow-up
Change in biologicals parameters
Changes in biological parameters, including serum ferritin and transferrin saturation (TSAT)
Measured: At baseline and 1 month follow-up
Change in biologicals parameters
Changes in biological parameters, including vitamins B9, B12, and D.
Measured: At baseline and 1 month follow-up
Malnutrition
The Mini Nutritional Assessment (Short Form) consists of six items assessing food intake, recent weight loss, mobility, acute disease or psychological stress, neuropsychological problems, and body mass index (BMI) or, when BMI cannot be calculated, calf circumference. The total score ranges from 0 to 14, with 12-14 indicating normal nutritional status, 8-11 indicating risk of malnutrition, and 0-7 indicating malnutrition.
Measured: At baseline and 1 month follow-up
Muscular and functional performance
Handgrip strength, measured in kilograms (kg) using a hand dynamometer.
Measured: At baseline and 1 month follow-up
Muscular and functional performance
Calf circumference of the non-operated leg, measured in centimeters (cm).
Measured: At baseline and 1 month follow-up
Muscular and functional performance
Walking speed over 4 metres, measured in m/s.
Measured: At baseline and 1 month follow-up
Muscular and functional performance
Time required to complete five chair stands measured in seconds.
Measured: At baseline and 1 month follow-up
Muscular and functional performance
Time required to complete the Timed Up and Go (TUG) test, measured in seconds.
Measured: At baseline and 1 month follow-up
Pain with VAS
Pain is assessed by a Visual Analogic scale graduated from 0 to 10 (0 = no pain, 10 = the worst pain imaginable)
Measured: At baseline and 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee AnthroplastyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782502
- Sponsor's protocol ID
- 2026-A01318-43
- Acronym
- ORTHONUTRI
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Nutritional Status of Patients Undergoing Prosthetic Orthopedic Surgery: An Exploratory Study
- ClinicalTrials.gov ID
- NCT07782502
- Acronym / sponsor ID
- ORTHONUTRI / 2026-A01318-43
- Conditions
- Total Knee Anthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Aug 2026 (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.
The aim of this study is to evaluate the impact of prosthetic orthopedic surgery on the nutritional status of patients undergoing total knee arthroplasty in adult patients scheduled.
This study is based on the hypothesis that prosthetic orthopedic surgery may induce or worsen malnutrition, an issue that has not been investigated to date.
Participants will perform an additionnal blood test, physical performance tests and questionnaires as part of this research.
Detailed description
Prosthetic joint surgery is now a major public health issue in France. According to data published by the French National Academy of Medicine, approximately 305,780 major joint arthroplasties were performed in 2017, representing a 39% increase over a ten-year period (219,826 procedures in 2006).
Malnutrition is common among patients undergoing major orthopedic surgery, with a reported prevalence of up to 50%, depending on the study population. Preoperative malnutrition has been associated with an increased risk of intraoperative events and postoperative complications.
Malnutrition is a modifiable biological risk factor. Optimizing nutritional status before total joint arthroplasty may improve the overall value of care while reducing the risk of intraoperative and postoperative complications.
A composite index combining serum albumin concentration and total lymphocyte count, the Prognostic Nutritional Index (PNI), has been developed to assess nutritional status. Among patients undergoing total knee arthroplasty, better perioperative nutritional status has been associated with improved clinical and functional outcomes, including reduced pain, better patient-reported outcome measures (PROMs), and improved knee biomechanics. These benefits have been shown to persist for more than one year after surgery. If many studies focus on the patient's nutritional status prior to surgery, very few have examined the impact of surgery on post-operative nutritional outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroscopy | Experimental | Diagnostic Test: Blood and physical performance testsTotal knee arthroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged ≥18 years at the time of surgery
- Patients scheduled for total knee arthroplasty.
- Patients enrolled in the preoperative Enhanced Recovery After Surgery (ERAS) pathway.
- Patients affiliated with or covered by a social security system.
- French-speaking patients who have provided written informed consent
Key exclusion criteria (3 listed)
- Patients scheduled for revision total knee arthroplasty
- Protected patients: adults under guardianship, curatorship, or other legal protection measures, or individuals deprived of liberty by judicial or administrative decision
- Patients hospitalized without consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and physical performance testsAdditional postoperative blood tests. Physical performance test (hand grip-test, measurement of the calf circumference of the non-operated leg, walking test, chair stand test and Timed Up \& Go test. | Diagnostic test | Total knee arthroscopy |
Primary outcome
Patients nutritional status
Time frame: At baseline and 1 month follow-up.
The primary outcome measure is the prevalence of patients with a low Prognostic Nutritional Index (PNI) (PNI < 40). PNI value ≥ 50: Normal; PNI value < 50: Mild malnutrition; PNI value< 45: Moderate to severe malnutrition; PNI value< 40: Serious malnutrition.
15 secondary outcomes
Change from Baseline in Prognostic Nutritional Index (PNI) at 1 Month
Time frame: At baseline and 1 month follow-up
Change in biologicals parameters
Time frame: At baseline and 1 month follow-up
Change in biologicals parameters (ionogram)
Time frame: At baseline and 1 month follow-up
Change in biologicals parameters
Time frame: At baseline and 1 month follow-up
Change in biologicals parameters
Time frame: At baseline and 1 month follow-up
Change in biologicals parameters
Time frame: At baseline and 1 month follow-up
Change in biologicals parameters
Time frame: At baseline and 1 month follow-up
Change in biologicals parameters
Time frame: At baseline and 1 month follow-up
Malnutrition
Time frame: At baseline and 1 month follow-up
Muscular and functional performance
Time frame: At baseline and 1 month follow-up
Muscular and functional performance
Time frame: At baseline and 1 month follow-up
Muscular and functional performance
Time frame: At baseline and 1 month follow-up
Muscular and functional performance
Time frame: At baseline and 1 month follow-up
Muscular and functional performance
Time frame: At baseline and 1 month follow-up
Pain with VAS
Time frame: At baseline and 1 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and physical performance tests in people with Total Knee Anthroplasty, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Aug 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patients nutritional status (time frame: At baseline and 1 month follow-up.). 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 24 Aug 2026.