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

Completed

Conditions studied: Arthritis

In brief

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.

Key facts

Study ID

NCT01545362

Run by

Heekin Orthopedic Research Institute

People needed

50

Starts

2011-11-01

Expected to finish

2016-11-01

Last updated by the study team

2017-01-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is a male or non-pregnant female over the age of 21.
• Patient requires a bilateral staged knee arthroplasty (within 7 days)
• Patient has signed and dated an IRB approved consent form.
• Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
• Patient has failed to respond to conservative treatment modalities.

You may not qualify if…

• Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
• Patient is a prisoner.
• Surgery on the second side cancelled or delayed past 7 days by patient request subject will be terminated from the study.
• BMI >35

Where it is running

• Heekin Orthopedic Specialists — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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