Assessment of the Nutritional Status of Patients Undergoing Prosthetic Orthopedic Surgery: An Exploratory Study

NCT07782502 | Not Yet Recruiting

• 1 other identifier: 2026-A01318-43
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Total Knee Anthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and 1 month follow-up.

Secondary Outcomes (15)

• Change from Baseline in Prognostic Nutritional Index (PNI) at 1 Month

  At baseline and 1 month follow-up

• Change in biologicals parameters

  At baseline and 1 month follow-up

• Change in biologicals parameters (ionogram)

  At baseline and 1 month follow-up

• Change in biologicals parameters

  At baseline and 1 month follow-up

• Change in biologicals parameters

  At baseline and 1 month follow-up

Study Arms (1)

Total knee arthroscopy

EXPERIMENTAL

Total knee arthroscopy

Diagnostic Test: Blood and physical performance tests

Interventions

Blood and physical performance tests DIAGNOSTIC_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.

Total knee arthroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique des Maussins

Paris, 75850, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)