NCT03549962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

May 27, 2018

Last Update Submit

March 21, 2022

Conditions

Keywords

PreoperativeNutritional StatusArthroplastyReplacementOsteoarthritisKnee

Outcome Measures

Primary Outcomes (1)

  • In-hospital postoperative complications

    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

    From March 2013 to December 2017

Interventions

TKAPROCEDURE

Total Knee Arthroplasty

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Revision of Total Knee Arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Department of Orthopaedics & Traumatology

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professional Consultant, Department of Orthopaedics & Traumatology; Director of MSc/PgD Programme in Musculoskeletal Medicine & Rehabilitation

Study Record Dates

First Submitted

May 27, 2018

First Posted

June 8, 2018

Study Start

January 31, 2020

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations