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Early Treatment for Acute ACL Tear (AAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01692756
Recruitment Status : Completed
First Posted : September 25, 2012
Results First Posted : November 13, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Cale Jacobs, University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Anterior Cruciate Ligament (ACL) Tears
Interventions Drug: Kenalog or placebo
Drug: Kenalog then Placebo
Drug: Kenalog
Drug: Placebo
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Period Title: Overall Study
Started 12 12 13 12
Completed 11 11 11 12
Not Completed 1 1 2 0
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo Total
Hide Arm/Group Description

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 11 11 11 12 45
Hide Baseline Analysis Population Description
One patient was lost to follow-up (Group 1). Two patients withdrew prior to receiving treatment (Group 2, Group 3). One patient did not attend first study visit and did not receive allocated intervention (Group 3).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 11 participants 12 participants 45 participants
18.45  (2.99) 19.60  (4.12) 24.06  (6.57) 17.80  (2.14) 19.9  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 11 participants 12 participants 45 participants
Female
3
  27.3%
4
  36.4%
5
  45.5%
7
  58.3%
19
  42.2%
Male
8
  72.7%
7
  63.6%
6
  54.5%
5
  41.7%
26
  57.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 11 participants 12 participants 45 participants
American Indian or Alaska Native
0
   0.0%
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%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   9.1%
0
   0.0%
1
   9.1%
4
  33.3%
6
  13.3%
White
10
  90.9%
10
  90.9%
10
  90.9%
8
  66.7%
38
  84.4%
More than one race
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
1
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 11 participants 12 participants 45 participants
11
 100.0%
11
 100.0%
11
 100.0%
12
 100.0%
45
 100.0%
Knee Injury and Osteoarthritis Scale (KOOS) Pain Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 11 participants 11 participants 12 participants 45 participants
49.75  (19.10) 58.33  (15.42) 50.25  (24.61) 46.30  (25.02) 51.05  (21.2)
[1]
Measure Description: KOOS consists of 5 subscales with five questions per scale; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The baseline KOOS Pain scores are presented here.
1.Primary Outcome
Title Participant Pain Assessment
Hide Description Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 4 patients (Group 1 n:1, Group 2 n:1, Group 4 n:2) overlooked completing the VAS. This was not realized until the patients had left the study visit preventing the investigator from collecting the information.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 11 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.9  (2.8) -2.2  (2.2) -3.6  (3.0) -4.3  (3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Secondary Outcome
Title Efficacy of Kenalog to Alleviate Knee Pain
Hide Description The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 11 11 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
37.37  (17.50) 18.94  (11.02) 30.56  (23.17) 28.93  (22.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
3.Secondary Outcome
Title Synovial Interleukin-1α (IL-1α) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
The values for 3 patients (Gp1 n:1, Gp 2 n:1, Gp 3 n:1) were below the limits of detection and were not included in the analysis.Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined 1 aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 9 9 9 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
4.30  (6.59) 7.68  (13.15) 1.77  (4.43) 3.11  (5.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title Synovial Interleukin-1β (IL-1β) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
The values for two patients (Gp1 n:1, Gp 2 n:1) were below the limits of detection and were not included in the analysis. Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined 1 aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 9 9 10 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
-1.08  (2.87) 0.75  (1.98) -0.28  (0.37) -0.19  (0.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Secondary Outcome
Title Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
-3352.5  (8285.5) -4955.6  (12,939.6) -7278.4  (12,581.9) -6888.5  (8364.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
6.Secondary Outcome
Title Synovial C-terminal Peptide II (CTXII) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Group 1 n:1, Group 2 n:1) and 1 patient declined the pre-op assessment aspiration (Group 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.32  (0.21) 0.23  (0.27) 0.19  (0.34) 1.32  (1.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
7.Secondary Outcome
Title Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Group 1 n:1, Group 2 n:1) and 1 patient declined the pre-op assessment aspiration (Group 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: μg/mL
-4.9  (17.5) -21.7  (24.1) -11.7  (7.1) -22.1  (5.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .007
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
8.Secondary Outcome
Title Synovial Glycosaminoglycans (GAG) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: μg/mL
-73.1  (176.7) 155.8  (132.4) -49.0  (252.5) -167.4  (140.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .63
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
9.Secondary Outcome
Title Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: µg/mL
3.5  (7.7) 0.6  (4.0) 2.6  (3.6) 5.8  (6.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
10.Secondary Outcome
Title Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: ng/ml
68.0  (266.0) 57.6  (244.5) 111.4  (180.5) -4.9  (224.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .62
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
11.Secondary Outcome
Title Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
249.0  (745.9) -183.0  (245.5) -395.5  (472.2) -100.4  (557.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
12.Secondary Outcome
Title Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
Hide Outcome Measure Data
Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
2702.9  (3937.2) 504.0  (1705.9) -512.4  (2175.0) 1295.9  (2414.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .20
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
13.Secondary Outcome
Title Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration
Hide Description Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Time Frame Up to seven days
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Hide Analysis Population Description
Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description:

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

Overall Number of Participants Analyzed 10 10 10 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
-71.1  (15.9) -28.9  (42.6) -17.7  (18.8) -14.0  (24.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kenalog or Placebo, Kenalog Then Placebo, Kenalog Only, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .87
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame Over the course of 12months.
Adverse Event Reporting Description Patients were approached and asked about any adverse events at regular study and/or clinic visits.
 
Arm/Group Title Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Hide Arm/Group Description

Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.

Kenalog or placebo

Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury.

Kenalog then Placebo

Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®

Kenalog

subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.

Placebo

All-Cause Mortality
Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/11 (0.00%)      0/11 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)      0/11 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Kenalog or Placebo Kenalog Then Placebo Kenalog Only Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/11 (63.64%)      4/11 (36.36%)      6/11 (54.55%)      5/12 (41.67%)    
Gastrointestinal disorders         
Nausea or Hives/Rash from post op pain meds   0/11 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1 1/12 (8.33%)  1
General disorders         
Knee Effusion Post-Op   1/11 (9.09%)  1 1/11 (9.09%)  1 0/11 (0.00%)  0 1/12 (8.33%)  1
Knee Effusion from Unanticipated Accident   1/11 (9.09%)  1 0/11 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Arthrofibrosis   1/11 (9.09%)  1 0/11 (0.00%)  0 2/11 (18.18%)  2 0/12 (0.00%)  0
Nosebleed   0/11 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Strep Throat   0/11 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0 1/12 (8.33%)  1
Persistent Low Leg Pain   0/11 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Stitch Abscess   0/11 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders         
ACL Re-Tear  [1]  4/11 (36.36%)  4 1/11 (9.09%)  1 0/11 (0.00%)  0 1/12 (8.33%)  1
Cervical Strain after Motor Vehicle Accident   0/11 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Infrapatella scarring/pain   0/11 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Re-Tear of the anterior cruciate ligament
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
Layout table for Results Point of Contact information
Name/Title: Cale Jacobs, ATC, PhD
Organization: Univerisity of Kentucky
Phone: 8592183065
EMail: Kycartilagedoc@gmail.com
Layout table for additonal information
Responsible Party: Cale Jacobs, University of Kentucky
ClinicalTrials.gov Identifier: NCT01692756    
Other Study ID Numbers: 12-0706
First Submitted: September 11, 2012
First Posted: September 25, 2012
Results First Submitted: April 2, 2018
Results First Posted: November 13, 2018
Last Update Posted: December 5, 2018