Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
R. David Heekin, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier:
NCT01545362
First received: March 1, 2012
Last updated: March 19, 2013
Last verified: March 2012

March 1, 2012
March 19, 2013
November 2011
December 2013   (final data collection date for primary outcome measure)
Blood loss until drain is pulled [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01545362 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Cohort selected from patients in orthopaedic clinic

Arthritis
Procedure: Total knee arthroplasty
Total knee arthroplasty
Staged bilateral total knee arthroplasty
Patients that have bilateral total knee arthroplasty staged within one week
Intervention: Procedure: Total knee arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
March 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01545362
2010-004
No
R. David Heekin, Heekin Orthopedic Research Institute
Heekin Orthopedic Research Institute
Not Provided
Principal Investigator: R. David Heekin, M.D. Heekin Institute for Orthopedic Research
Heekin Orthopedic Research Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP