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Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03694925
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos Higuera-Rueda, The Cleveland Clinic

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Prosthetic Joint Infection
Intervention Diagnostic Test: Calprotectin test
Enrollment 156
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Primary Total Knee Arthroplasty Aseptic Revision Total Knee Arthroplasty Revision Septic Total Knee Arthroplasty
Hide Arm/Group Description

Primary TKA patients included in the study, to provide a baseline level for calprotectin.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Period Title: Overall Study
Started 30 73 53
Completed 30 70 53
Not Completed 0 3 0
Reason Not Completed
Inadequate laboratory testing             0             3             0
Arm/Group Title Primary Total Knee Arthroplasty Aseptic Revision Total Knee Arthroplasty Revision Septic Total Knee Arthroplasty Total
Hide Arm/Group Description

Primary TKA patients included in the study, to provide a baseline level for calprotectin.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Total of all reporting groups
Overall Number of Baseline Participants 30 70 53 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 70 participants 53 participants 153 participants
67.2  (9.8) 65.4  (10.6) 68.8  (10.2) 66.9  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 70 participants 53 participants 153 participants
Female
17
  56.7%
40
  57.1%
26
  49.1%
83
  54.2%
Male
13
  43.3%
30
  42.9%
27
  50.9%
70
  45.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 70 participants 53 participants 153 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  16.7%
11
  15.7%
6
  11.3%
22
  14.4%
White
25
  83.3%
58
  82.9%
47
  88.7%
130
  85.0%
More than one race
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 30 participants 70 participants 53 participants 153 participants
34.2  (5.9) 32.0  (6.2) 34.2  (9.7) 33.2  (7.6)
Charlson Comorbidity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale from 0 to 27
Number Analyzed 30 participants 70 participants 53 participants 153 participants
3.4  (2.0) 3.4  (1.9) 4.6  (2.5) 3.8  (2.2)
[1]
Measure Description: The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. Points are additionally added for age based on decade of life. A score of zero indicates that no comorbidities were found. Minimum is 0. Max is 27.
Erythrocyte Sedimentation Rate   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mm/hr
Number Analyzed 0 participants 70 participants 51 participants 121 participants
14  (11) 57  (35) 33  (32)
[1]
Measure Description: An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. Normally, red blood cells settle relatively slowly. A faster-than-normal rate may indicate inflammation in the body.
[2]
Measure Analysis Population Description: ESR was not collected for primary TKA as it is not standard of care ESR was not ordered by the physician for 2 septic cases
C Reactive Protein   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 0 participants 70 participants 52 participants 122 participants
0.6  (0.7) 11.8  (14.6) 5.4  (11.0)
[1]
Measure Description: C-reactive protein (CRP) is a protein made by the liver. CRP levels in the blood increase when there is a condition causing inflammation somewhere in the body. A CRP test measures the amount of CRP in the blood to detect inflammation due to acute conditions or to monitor the severity of disease in chronic conditions.
[2]
Measure Analysis Population Description: CRP was not collected for primary TKA as it is not standard of care CRP was not ordered by the physician for the 1 septic case
Synovial WBC Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Cells/ micro liter
Number Analyzed 0 participants 70 participants 52 participants 122 participants
735  (856) 57803  (66595) 25059  (51598)
[1]
Measure Analysis Population Description: Synovial WBC was not collected for primary TKA as it is not standard of care Synovial WBC was unable to be run due to insufficient quantity for the 1 septic case
Synovial PMN%   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of cells
Number Analyzed 0 participants 70 participants 51 participants 121 participants
21  (24) 89  (13) 50  (39)
[1]
Measure Analysis Population Description: Synovial PMN% was not collected for primary TKA as it is not standard of care Synovial PMN% was unable to be run due to insufficient quantity for 2 septic cases
Current Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 70 participants 53 participants 153 participants
1
   3.3%
5
   7.1%
7
  13.2%
13
   8.5%
Type of Surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Aseptic Revision Number Analyzed 30 participants 70 participants 53 participants 153 participants
0
   0.0%
68
  97.1%
0
   0.0%
68
  44.4%
DAIR Number Analyzed 30 participants 70 participants 53 participants 153 participants
0
   0.0%
1
   1.4%
18
  34.0%
19
  12.4%
1st Stage of a 2 Stage Number Analyzed 30 participants 70 participants 53 participants 153 participants
0
   0.0%
1
   1.4%
34
  64.2%
35
  22.9%
1 Stage Number Analyzed 30 participants 70 participants 53 participants 153 participants
0
   0.0%
0
   0.0%
1
   1.9%
1
   0.7%
Primary Number Analyzed 30 participants 70 participants 53 participants 153 participants
30
 100.0%
0
   0.0%
0
   0.0%
30
  19.6%
Calprotectin POC Result   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Low Risk Number Analyzed 30 participants 70 participants 53 participants 153 participants
29
  96.7%
61
  87.1%
1
   1.9%
91
  59.5%
Moderate Risk Number Analyzed 30 participants 70 participants 53 participants 153 participants
0
   0.0%
6
   8.6%
0
   0.0%
6
   3.9%
High Risk Number Analyzed 30 participants 70 participants 53 participants 153 participants
1
   3.3%
3
   4.3%
52
  98.1%
56
  36.6%
[1]
Measure Description:

Low Risk is defined 0-14 mg/L Medium Risk is defined as 14-50 mg/L High Risk is defined as >50 mg/L

The risk refers to risk of PJI

Calprotectin ELISA Result   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Low Risk Number Analyzed 30 participants 70 participants 53 participants 153 participants
29
  96.7%
58
  82.9%
1
   1.9%
88
  57.5%
Moderate Risk Number Analyzed 30 participants 70 participants 53 participants 153 participants
0
   0.0%
9
  12.9%
0
   0.0%
9
   5.9%
High Risk Number Analyzed 30 participants 70 participants 53 participants 153 participants
1
   3.3%
3
   4.3%
52
  98.1%
56
  36.6%
[1]
Measure Description:

Low Risk is defined 0-14 mg/L Medium Risk is defined as 14-50 mg/L High Risk is defined as >50 mg/L

The risk refers to risk of PJI

Sinus Tract   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 70 participants 53 participants 123 participants
0
0
   0.0%
14
  26.4%
14
  11.4%
[1]
Measure Description:

A tunneling wound or sinus tract is a narrow opening or passageway extending from a wound underneath the skin in any direction through soft tissue and results in dead space with potential for abscess formation.

This was observed during surgery and collected from the operative note. This is not an outcome measure, rather it is used to assist in classifying a case as septic or aseptic using the Musculoskeletal Infection Society criteria for PJI. By definition all patients with a sinus tract are septic, however not all septic cases have a sinus tract.

[2]
Measure Analysis Population Description: MSIS criteria was only applied to septic and aseptic cases.
Cultures   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
2 or more positive cultures Number Analyzed 0 participants 70 participants 53 participants 123 participants
0
   0.0%
33
  62.3%
33
  26.8%
1 positive culture Number Analyzed 0 participants 70 participants 53 participants 123 participants
9
  12.9%
47
  88.7%
56
  45.5%
0 positive cultures Number Analyzed 0 participants 70 participants 53 participants 123 participants
62
  88.6%
6
  11.3%
68
  55.3%
[1]
Measure Analysis Population Description: Cultures were not ordered on primary TKAs as they are not standard of care
Histopathology   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Positive Number Analyzed 0 participants 66 participants 38 participants 104 participants
3
   4.5%
33
  86.8%
36
  34.6%
Negative Number Analyzed 0 participants 66 participants 38 participants 104 participants
63
  95.5%
5
  13.2%
68
  65.4%
[1]
Measure Analysis Population Description:

Histopathology was not ordered on primary TKAs as they are not standard of care.

It was not ordered for a number septic and aseptic cases due to the individual preferences of the surgeon.

1.Primary Outcome
Title Calprotectin POC
Hide Description lateral flow point of care test
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Total Knee Arthroplasty Aseptic Revision Total Knee Arthroplasty Revision Septic Total Knee Arthroplasty
Hide Arm/Group Description:

There will be n=30 primary TKA patients included in the study, to provide a baseline level for calprotectin.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

There will be n=70 aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

There will be n=50 septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Overall Number of Participants Analyzed 30 70 53
Measure Type: Count of Participants
Unit of Measure: Participants
Positive at >50 mg/L
1
   3.3%
3
   4.3%
52
  98.1%
Negative at >50 mg/L
29
  96.7%
67
  95.7%
1
   1.9%
Positive at >14 mg/L
1
   3.3%
9
  12.9%
52
  98.1%
Negative at >14 mg/L
29
  96.7%
61
  87.1%
1
   1.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value .871
Estimation Comments Specificity was calculated using 2x2 tables using >14 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value .957
Estimation Comments Specificity was calculated using 2x2 tables using >50 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value .981
Estimation Comments Sensitivity was calculated using 2x2 tables using >14 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value .981
Estimation Comments Sensitivity was calculated using 2x2 tables using >50 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Positive predictive value
Estimated Value .852
Estimation Comments Positive predictive value was calculated using 2x2 tables using >14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Positive predictive value
Estimated Value .945
Estimation Comments Positive predictive value was calculated using 2x2 tables using >50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Negative predictive value
Estimated Value .984
Estimation Comments Negative predictive value was calculated using 2x2 tables using >14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Negative predictive value
Estimated Value .985
Estimation Comments Negative predictive value was calculated using 2x2 tables using >50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.
2.Secondary Outcome
Title Calprotectin ELISA
Hide Description ELISA analysis
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Total Knee Arthroplasty Aseptic Revision Total Knee Arthroplasty Revision Septic Total Knee Arthroplasty
Hide Arm/Group Description:

There will be n=30 primary TKA patients included in the study, to provide a baseline level for calprotectin.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

There will be n=70 aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

There will be n=50 septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Overall Number of Participants Analyzed 30 70 53
Measure Type: Count of Participants
Unit of Measure: Participants
Positive at >50 mg/L
1
   3.3%
3
   4.3%
52
  98.1%
Negative at >50 mg/L
29
  96.7%
67
  95.7%
1
   1.9%
Positive at >14 mg/L
1
   3.3%
12
  17.1%
52
  98.1%
Negative at >14 mg/L
29
  96.7%
58
  82.9%
1
   1.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value .829
Estimation Comments Specificity was calculated using 2x2 tables using >14 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value .957
Estimation Comments Specificity was calculated using 2x2 tables using >50 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value .981
Estimation Comments Sensitivity was calculated using 2x2 tables using >14 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value .981
Estimation Comments Sensitivity was calculated using 2x2 tables using >50 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Positive predictive value
Estimated Value .813
Estimation Comments Positive predictive value was calculated using 2x2 tables using >14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Positive predictive value
Estimated Value .945
Estimation Comments Positive predictive value was calculated using 2x2 tables using >50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Negative predictive value
Estimated Value .983
Estimation Comments Negative predictive value was calculated using 2x2 tables using >14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Aseptic Revision Total Knee Arthroplasty, Revision Septic Total Knee Arthroplasty
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Negative predictive value
Estimated Value .985
Estimation Comments Negative predictive value was calculated using 2x2 tables using >50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.
Other Statistical Analysis Negative predictive value was calculated using 2x2 tables using >50 mg/L cut off. NPV=98.5%
3.Post-Hoc Outcome
Title Area Under the Curve
Hide Description

Area under the curve (AUC) was calculated using receiver operator characteristic (ROC) curve using the two cut offs (>14 mg/L and >50 mg/L) for both the ELISA and POC tests. Data were collected intraoperatively during the patient's arthroplasty surgery.

AUC - ROC curve is a performance measurement for classification problem at various thresholds settings. ROC is a probability curve and AUC represents degree or measure of separability. It tells how much model is capable of distinguishing between classes. Higher the AUC, better the model is at predicting 0s as 0s (aseptics that are negative) and 1s as 1s (septics that are positive). 1.000 represents accurately predicting each aseptic as negatve and each septic as positive. While a 0.000 represents accurately predicting each aseptic as positive and each septic as negative.

Time Frame From completion of first patient's ELISA and POC test to last patient's ELISA and POC test
Hide Outcome Measure Data
Hide Analysis Population Description
Primary TKAs were no analyzed as AUC is a binary analysis representing the accuracy of predicting the correct diagnosis, ie (an aseptic is an negative, or a septic is positive). Arms/Groups are combined as the data represents the accuracy of all septics and aseptics combined at a given threshold for either the POC or ELISA test. This assessment was pre-specified to combine Arms.
Arm/Group Title Primary Total Knee Arthroplasty Combined Revision Total Knee Arthroplasty
Hide Arm/Group Description:

Primary TKA patients included in the study, to provide a baseline level for calprotectin.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

All revision TKA patients included in the study.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

Overall Number of Participants Analyzed 0 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
POC Test >50 mg/L
0.969
(0.934 to 1.000)
POC Test >14 mg/L
0.926
(0.875 to 0.978)
ELISA Test >50 mg/L
0.969
(0.934 to 1.000)
ELISA Test >14 mg/L
0.905
(0.847 to 0.962)
Time Frame Adverse events were collected during the the collection of the synovial fluid sample on the day of surgery which was approximately 10 minutes from incision
Adverse Event Reporting Description The clinicaltrials.gov definition was used
 
Arm/Group Title Primary Total Knee Arthroplasty Aseptic Revision Total Knee Arthroplasty Revision Septic Total Knee Arthroplasty
Hide Arm/Group Description

There will be n=30 primary TKA patients included in the study, to provide a baseline level for calprotectin.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

There will be n=70 aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

There will be n=50 septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.

Calprotectin test: Calprotectin will be measured both by ELISA and point of care test.

All-Cause Mortality
Primary Total Knee Arthroplasty Aseptic Revision Total Knee Arthroplasty Revision Septic Total Knee Arthroplasty
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/73 (0.00%)   0/53 (0.00%) 
Hide Serious Adverse Events
Primary Total Knee Arthroplasty Aseptic Revision Total Knee Arthroplasty Revision Septic Total Knee Arthroplasty
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/73 (0.00%)   0/53 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Primary Total Knee Arthroplasty Aseptic Revision Total Knee Arthroplasty Revision Septic Total Knee Arthroplasty
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/73 (0.00%)   0/53 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Alison Klika
Organization: Cleveland Clinic Arthroplasty Research Group
Phone: 4123017914
EMail: klikaa@ccf.org
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Responsible Party: Carlos Higuera-Rueda, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03694925    
Other Study ID Numbers: 18-882
First Submitted: October 2, 2018
First Posted: October 3, 2018
Results First Submitted: June 8, 2020
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020