Back to resultsStatic vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
Primary Purpose
Prosthetic Joint Infection of the Knee
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Static Antibiotic Spacer Surgical Implant
Articulating Antibiotic Spacer Surgical Implant
Sponsored by
About this trial
This is an interventional treatment trial for Prosthetic Joint Infection of the Knee
Eligibility Criteria
Inclusion Criteria
- Male or female age 18 to 100 years of age.
- 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.
- Intact extensor mechanism.
- Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
- Adequate bone stock for knee reconstruction
- Medical fitness for staged knee reconstruction
Exclusion Criteria
- Known Atypical infection (mycobacterial or fungal)
- Extensor mechanism disruption
- Inadequate soft tissue envelope requiring muscle flap or skin grafting
- Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
- Medical status precluding staged knee reconstruction
- Requirement for hinged knee reconstruction at the time of reimplantation
- Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Static Antibiotic Spacer
Articulating Antibiotic Spacer
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Subjects With Repeat Infections
The rate of repeat infections after re-implantation Total Knee Arthroplasty.
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.
Secondary Outcome Measures
Pre-operative Range of Motion (ROM)
The degree of knee flexion was measured pre-operatively.
Post-operative Range of Motion (ROM)
The degree of knee flexion was measured one year post-operatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02547129
Brief Title
Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
Official Title
A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty enrolling patients as patients wanted articulating spacers.
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
January 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infection of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Static Antibiotic Spacer
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Articulating Antibiotic Spacer
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Static Antibiotic Spacer Surgical Implant
Intervention Description
Joint spacer for treatment of joint infection
Intervention Type
Device
Intervention Name(s)
Articulating Antibiotic Spacer Surgical Implant
Intervention Description
Joint spacer for treatment of joint infection
Primary Outcome Measure Information:
Title
Number of Subjects With Repeat Infections
Description
The rate of repeat infections after re-implantation Total Knee Arthroplasty.
Time Frame
1 year post-operatively
Title
Change in Total Knee Replacement Functional Scores
Description
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.
Time Frame
baseline, 1 year post-operatively
Secondary Outcome Measure Information:
Title
Pre-operative Range of Motion (ROM)
Description
The degree of knee flexion was measured pre-operatively.
Time Frame
baseline
Title
Post-operative Range of Motion (ROM)
Description
The degree of knee flexion was measured one year post-operatively.
Time Frame
1 year post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Male or female age 18 to 100 years of age.
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.
Intact extensor mechanism.
Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
Adequate bone stock for knee reconstruction
Medical fitness for staged knee reconstruction
Exclusion Criteria
Known Atypical infection (mycobacterial or fungal)
Extensor mechanism disruption
Inadequate soft tissue envelope requiring muscle flap or skin grafting
Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
Medical status precluding staged knee reconstruction
Requirement for hinged knee reconstruction at the time of reimplantation
Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Taunton, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty
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