Clinical Trial: Static vs. Articulating Antibiotic Spacer for PJI in TKA

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty

Brief Summary: What is the difference in the outcomes of patients treated with an articulating antibiotic spacer versus a static articulating spacer in the setting of two stage exchange for infected total knee arthroplasty?

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: Preoperative functional scores improved (p,/=0.0001) [ Time Frame: Assessed for 1 year following surgical treatment ]

from a median of 5 points to a median of 50 points (range 0 - 100 points) post-operatively.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pre-operative range of motion (ROM) [ Time Frame: Assessed for 1 year following surgical treatment ]
    in the 81 knees that did not have major surgery had a median of 85 degree (range 30 - 125 degrees)
  • Range of Motion at last study follow-up visit [ Time Frame: 1 year ]
    had a median of 90 degrees (rang 30 - 120 degrees)


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: August 18, 2015
Date Started: September 2015
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017