Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty

Not Applicable

Terminated

• Conditions: Prosthetic Joint Infection of the Knee

• Registration Number: NCT02547129
• Lead Sponsor: Mayo Clinic

Brief Summary

The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-18
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Primary Completion: 2017-01-23
• Study Completion: 2017-01-23
• Results First Submitted: 2018-04-25
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-19
• Last Update Submitted: 2019-04-19
• Results First Posted: 2019-05-15
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Repeat Infections	1 year post-operatively	The rate of repeat infections after re-implantation Total Knee Arthroplasty.
Change in Total Knee Replacement Functional Scores	baseline, 1 year post-operatively	Functional scores were measured using the Knee Society Score, a clinical standard for rating the outcome of total knee replacements. Scores range from 0 -100, where a higher score reflects a more positive outcome for the subject.

Secondary Outcome Measures

Name	Time	Method
Pre-operative Range of Motion (ROM)	baseline	The degree of knee flexion was measured pre-operatively.
Post-operative Range of Motion (ROM)	1 year post-operatively	The degree of knee flexion was measured one year post-operatively.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States