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Preoperative Nutritional Status in Patients Undergoing Elective Total Knee Arthroplasty and In-hospital Postoperative Complications (NUTR TKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03549962
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : March 30, 2020
Information provided by (Responsible Party):
Dr. Ho Ki Wai, Chinese University of Hong Kong

Brief Summary:

Malnutrition has long been linked to postoperative complications and adverse outcomes in a variety of surgical fields , such as increased susceptibility to infection, delayed wound healing, and increased frequency of decubitus ulcers. In particular, it is a modifiable risk factor, as evident by studies that have associated optimization of preoperative nutrition with improved surgical outcomes. Therefore, it is important to identify these patients who are at risk so that appropriate nutritional support can be implemented.

A range of options for nutritional status assessment have been proposed; a comprehensive assessment may include measurements of dietary intake, clinical assessment, anthropometric measurements, and biochemical measurements of serum protein, micronutrients and metabolic parameters . Many of the signs of malnutrition, however, only manifest in extreme cases. Thus it is crucial to identify sensitive markers that can be utilized to screen for clinical as well as subclinical malnutrition patients.

In orthopaedic patients, the prevalence of clinical and subclinical malnutrition has been reported to be up to 42.4%. Common markers of malnutrition that have been studied include low serum albumin as a marker of protein status, low total lymphocyte count (TLC), and excessively high or low body mass index (BMI). They have been compared against various adverse surgical outcomes, including surgical site infections (SSI), delayed wound healing, unplanned intubation and ICU admission , postoperative anemia and cardiac complications , and length of hospital stay. However, conflicting results have been reported; for example, while hypoalbuminemia (serum albumin <3.5mg/dL) have been associated with increased risk of SSI and longer than average hospital stay, its effect on wound healing is less clear - Marin et al. reported no significant predictive value of hypoalbuminemia on wound healing, yet Greene et al. reported a 5-time increase in frequency of major wound complication.

The purpose of this retrospective cohort study was to identify biomarkers of malnutrition in patients undergoing elective total knee arthroplasty (TKA) that are predictive of adverse in-hospital postoperative complications, which would facilitate the identification of at risk patients for nutritional optimization before surgery.

Six-hundred and twenty-six patients who underwent elective TKA between 2013 and 2017 in the Prince of Wales Hospital in Hong Kong were reviewed; the preoperative serum albumin, TLC, and BMI were compared against in-hospital postoperative complications.

Condition or disease Intervention/treatment
Preoperative Period Nutritional Status Arthroplasty Knee Procedure: TKA

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Study Type : Observational
Estimated Enrollment : 626 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Obesity is a Predictor of In-hospital Postoperative Complications in Patients Undergoing Elective Total Knee Arthroplasty
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: TKA
    Total Knee Arthroplasty

Primary Outcome Measures :
  1. In-hospital postoperative complications [ Time Frame: From March 2013 to December 2017 ]
    deep surgical site or implant infection, hematoma requiring drainage, wound complications, systemic infection with identifiable source, unplanned intensive care unit (ICU) admission, deep vein thrombosis (DVT), pulmonary embolism (PE), neurological complications, acute renal failure, and cardiovascular complications

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All elective Total Knee Arthroplasty cases from 2013 to 2017undergone elective Total Knee Arthroplasty in Prince of Wales Hospital Hong Kong

Inclusion Criteria:

  • All elective Total Knee Arthroplasty cases from 2013 to 2017
  • All patients must have undergone elective Total Knee Arthroplasty in Prince of Wales Hospital Hong Kong

Exclusion Criteria:

  • Revision of Total Knee Arthroplasty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03549962

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Hong Kong
Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Ki-Wai Ho, MBChB    (852) 3505 2715   
Department of Orthopaedics & Traumatology Completed
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Dr. Ho Ki Wai, Clinical Professional Consultant, Department of Orthopaedics & Traumatology; Director of MSc/PgD Programme in Musculoskeletal Medicine & Rehabilitation, Chinese University of Hong Kong Identifier: NCT03549962    
Other Study ID Numbers: CUHK_2018.242
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Ho Ki Wai, Chinese University of Hong Kong:
Nutritional Status
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes