An observational study in Periprosthetic Joint Infection (PJI), Malnutitrion and Postoperative Complication, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Assiut University · Observational
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."
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.
1,267 studies on the registry are indexed under Postoperative Complications; 299 are open to participants now.
This study's planned enrollment of 50 is below the median of 251 across 531 observational studies indexed under Postoperative Complications.
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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.
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Exclusion Criteria:
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.
Time frame: Up to 6 months
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.
Time frame: up to 6 months
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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