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

NCT01545362 | Completed

• 1 other identifier: 2010-004
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• Blood loss until drain is pulled

  postoperatively

Study Arms (1)

Staged bilateral total knee arthroplasty

Patients that have bilateral total knee arthroplasty staged within one week

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

Total knee arthroplasty

Staged bilateral total knee arthroplasty

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort selected from patients in orthopaedic clinic

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

Sponsors & Collaborators

• Heekin Orthopedic Research Institute: lead

Study Sites (1)

Heekin Orthopedic Specialists

Jacksonville, Florida, 32204, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• R. David Heekin, M.D.

  Heekin Institute for Orthopedic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 6, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

US (1)