Periprosthetic Joint Infection (PJI)CONUT (ControlNCT07884006
Impact of Nutritional Status Before Joint Replacement on Infection Risk
An observational study of Periprosthetic Joint Infection (PJI) and Malnutitrion, run by Assiut University at 1 site in Egypt.
Trial summary
Periprosthetic joint infection (PJI) is a serious complication after joint replacement surgery and is difficult to treat. Poor nutritional status may impair the body's ability to recover and fight infection, as well as increase the risk of postoperative problems. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Periprosthetic Joint Infection (PJI), Malnutitrion, Postoperative Complication
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2026to 30 Oct 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study subjects will be adult patients who will be undergoing primary total hip or knee arthroplasty at Assiut University Hospitals. Patients who qualify will be enrolled before surgery in a prospective manner. The nutritional status before the surgery will be evaluated by the Controlling Nutritional Status (CONUT) score, which is calculated from serum albumin, total cholesterol, and total lymphocyte count. Patients will be followed postoperative to assess the occurrence of periprosthetic joint infection and other postoperative complications.
Who may be able to join
- Patients aged 40 years or older who undergo primary joint arthroplasty, including knee arthroplasty and hip arthroplasty, who have complete preoperative laboratory data required for calculation of the CONUT score and provide written informed consent will be included.
Who cannot join
- Patients who had undergone revision surgery, suffered from active infections, had malignancies, or had incomplete follow-up will not be included in our study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut, Asyut Governorate, 71515
Omar Mohammed dr, Master candidate, 01004141347, am88super@gmail.com
About this study
Official title: Impact of Preoperative Nutritional Status (CONUT Score) on Periprosthetic Joint Infection Risk After Joint Arthroplasty
Periprosthetic joint infection (PJI) is a serious complication after joint replacement surgery and is difficult to treat. Poor nutritional status may impair the body's ability to recover and fight infection, as well as increase the risk of postoperative problems. The CONUT (Controlling Nutritional Status) score is a nutritional assessment tool that is based on 3 standard blood parameters, serum albumin, total cholesterol and total lymphocyte count. This study is a prospective observational study to investigate the association of preoperative nutritional status as defined by CONUT score and the risk of periprosthetic joint infection in patients undergoing joint arthroplasty. Preoperative nutritional assessment and postoperative follow-up will be performed to detect the occurrence of periprosthetic joint infection. We are studying whether a higher preoperative CONUT score is associated with a higher risk of infection after joint replacement surgery. The findings may help to identify those who are at increased risk of surgical infection and promote better preoperative assessment and patient care."
Read the detailed description
Periprosthetic joint infection (PJI) is one of the most challenging complications after joint arthroplasty, which may result in prolonged hospitalization, additional surgical procedures, increased healthcare costs, and decreased patient outcomes.
The preoperative nutritional status might have an important role in postoperative recovery, wound healing and immune function. Malnutrition has been linked to higher risk of postoperative complications including surgical site infections.
The CONUT (Controlling Nutritional Status) score is an objective nutritional screening tool based on serum albumin concentration, total cholesterol concentration, and peripheral blood lymphocyte count. Provides an assessment of nutritional and immune status.
In this prospective observational cohort study, we examined the relationship between pre-operative CONUT scores and the development of periprosthetic joint infection in patients undergoing joint arthroplasty.
Preoperative demographic, clinical and laboratory data will be collected. The CONUT score will be calculated based on routine preoperative laboratory parameters.
Standard surgical and post-operative care according to institutional clinical protocols will be provided to patients. There will be no experimental intervention or assignment to treatment in this study.
Postoperatively patients will be followed up for the occurrence of periprosthetic joint infection based on the diagnostic criteria described in the literature.
The main aim is to assess the correlation between preoperative CONUT scores and postoperative periprosthetic joint infection.
Statistical analyzes adjusting for relevant potential confounding factors will be used to examine the association between nutritional status and risk of infection.
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of periprosthetic joint infection
The rate of patients who develop periprosthetic joint infection (PJI) after primary joint arthroplasty. PJI will be diagnosed based on the established diagnostic criteria. The incidence of PJI will be evaluated in relation to preoperative nutritional status assessed by the Controlling Nutritional Status (CONUT) score.
Measured: Up to 6 months
Secondary outcomes (1)
Wound-Healing Complications
Secondary outcomes will include surgical site infection, wound-healing complications, length of hospital stay, ICU admission, hospital readmission, reoperation, postoperative pain, and functional recovery, depending on the type of joint arthroplasty performed.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Joint Infection (PJI)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohammed Abdullah Naji, Assiut University
- Investigators
- Hatem Mohamed Mohamed, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884006
- Sponsor's protocol ID
- AssiutU-CONUT-PJI-2026
- Acronym
- CONUT (Control
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared to protect patient privacy and confidentiality. Study findings will be reported in an aggregated and anonymized format through scientific publications and presentations.
Publications
Almeida PR, Mokete L, Sikhauli N, Mota A, Ndindwa B, Pietrzak JRT. Malnutrition in total joint arthroplasty: what should the orthopaedic surgeon consider? EFORT Open Rev. 2024 Jul 1;9(7):615-624. doi: 10.1530/EOR-23-0192.
PubMed 38949153Yavuz Veizi BG, Guven S, Demir C, Erdogan Y, Veizi E, Firat A. The role of preoperative nutritional status in predicting surgical outcomes after total knee arthroplasty: A CONUT-based analysis. Jt Dis Relat Surg. 2025 Jul 21;36(3):604-611. doi: 10.52312/jdrs.2025.2412. Epub 2025 Jul 21.
PubMed 40783992Ignacio de Ulibarri J, Gonzalez-Madrono A, de Villar NG, Gonzalez P, Gonzalez B, Mancha A, Rodriguez F, Fernandez G. CONUT: a tool for controlling nutritional status. First validation in a hospital population. Nutr Hosp. 2005 Jan-Feb;20(1):38-45.
PubMed 15762418Hill GL, Blackett RL, Pickford I, Burkinshaw L, Young GA, Warren JV, Schorah CJ, Morgan DB. Malnutrition in surgical patients. An unrecognised problem. Lancet. 1977 Mar 26;1(8013):689-92. doi: 10.1016/s0140-6736(77)92127-4.
PubMed 66485Azzolino D, Lucchi T. Malnutrition in older adults: a wider view. Lancet. 2023 Nov 25;402(10416):1976. doi: 10.1016/S0140-6736(23)01780-4. No abstract available.
PubMed 38007257Chen Y, Chen W. Association between malnutrition status and total joint arthroplasty periprosthetic joint infection and surgical site infection: a systematic review meta-analysis. J Orthop Surg Res. 2024 Oct 15;19(1):660. doi: 10.1186/s13018-024-05165-1.
PubMed 39407322