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 ]
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