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
  Purpose

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.


Condition Intervention
Arthritis
Procedure: Total knee arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Replacements Performed Within One Week

Resource links provided by NLM:


Further study details as provided by Heekin Orthopedic Research Institute:

Primary Outcome Measures:
  • Blood loss until drain is pulled [ Time Frame: postoperatively ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Staged bilateral total knee arthroplasty
Patients that have bilateral total knee arthroplasty staged within one week
Procedure: Total knee arthroplasty
Total knee arthroplasty

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cohort selected from patients in orthopaedic clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545362

Locations
United States, Florida
Heekin Orthopedic Specialists
Jacksonville, Florida, United States, 32204
Sponsors and Collaborators
Heekin Orthopedic Research Institute
Investigators
Principal Investigator: R. David Heekin, M.D. Heekin Institute for Orthopedic Research
  More Information

No publications provided

Responsible Party: R. David Heekin, Principal Investigator, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier: NCT01545362     History of Changes
Other Study ID Numbers: 2010-004
Study First Received: March 1, 2012
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014