Clinical Trials Directory

Trials / Completed

CompletedNCT01545362

Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Arthroplasty

The Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Replacements Performed Within One Week

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Heekin Orthopedic Research Institute · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

To determine if preop nutritional status is an indicator for outcomes of bilateral staged total knee arthroplasty. The investigators expect that patients having staged bilateral total knee arthroplasty with the second procedure performed within one week of the first and have a total lymphocyte count \>1500 per cubic millimeter and serum albumin level \>35 grams per liter will have the same or less complications and shorter length of stay than those with lower lymphocyte count and albumin level.

Detailed description

Association of malnutrition with postoperative complications after TKA has been reported in the form of increased rate of periprosthetic infection, longer hospital stay, etc. Reduced serum albumin and total lymphocyte count are commonly used to define malnutrition. The goal was to evaluate the impact of the nutritional status on the outcomes of primary staged bilateral TKAs performed one-week apart during two separate hospitalizations. Fifty consecutive patients with mean age of 67 years, mean BMI of 28.9 and 2.3 mean ASA score were followed for one year. Prior to the first surgery 32% had a TLC \<1500 cells/mm3 and 84% had a SA \<3.5 g/dL. Before the second surgery 62% had a reduced TLC and all but one had a reduced SA. Nine patients had a total of 12 perioperative blood transfusions (2 after the first surgery and 10 after the second surgery). The average length of stay was 3 days after each TKA. None of the patients with the lowest TLC or SA before the first or the second stage had a revision. Bilateral TKAs performed seven days apart in two separate hospitalizations is a safe and practical approach for qualified patients. The postoperative course was similar after each surgery. The preoperative nutritional status defined by TLC and SA did not influence the postoperative outcomes.

Conditions

Interventions

TypeNameDescription
PROCEDURETotal knee arthroplastyTotal knee arthroplasty

Timeline

Start date
2011-11-01
Primary completion
2016-11-01
Completion
2016-11-01
First posted
2012-03-06
Last updated
2017-01-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01545362. Inclusion in this directory is not an endorsement.