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

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

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.

Study Overview

• Status: Terminated
• Conditions: Prosthetic Joint Infection of the Knee
• Intervention / Treatment: Device: Static Antibiotic Spacer Surgical Implant; Device: Articulating Antibiotic Spacer Surgical Implant

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Male or female age 18 to 100 years of age.
2. Preoperative diagnosis of bacterial infection by culture which would include a preoperative aspiration and at least three intraoperative cultures. The preoperative aspiration would also be sent for a cell count with differential. All patients would have an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) drawn in the preoperative phase. Patients with a negative preoperative aspiration, but an actively draining wound or draining sinus tract, would be considered as infected. Intraoperative histopathology would also be obtained in all cases of infected total knee replacement at the time of the resection.
3. Intact extensor mechanism.
4. Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
5. Adequate bone stock for knee reconstruction
6. Medical fitness for staged knee reconstruction

Exclusion Criteria

1. Known Atypical infection (mycobacterial or fungal)
2. Extensor mechanism disruption
3. Inadequate soft tissue envelope requiring muscle flap or skin grafting
4. Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
5. Medical status precluding staged knee reconstruction
6. Requirement for hinged knee reconstruction at the time of reimplantation
7. Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Static Antibiotic Spacer; Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.	Device: Static Antibiotic Spacer Surgical Implant; Joint spacer for treatment of joint infection
ACTIVE_COMPARATOR: Articulating Antibiotic Spacer; Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.	Device: Articulating Antibiotic Spacer Surgical Implant; Joint spacer for treatment of joint infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Repeat Infections	The rate of repeat infections after re-implantation Total Knee Arthroplasty.	1 year post-operatively
Change in Total Knee Replacement Functional Scores	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.	baseline, 1 year post-operatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): January 23, 2017
• Study Completion (ACTUAL): January 23, 2017

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (ESTIMATE): September 11, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: 12-003291

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes