Trial Outcomes & Findings for Early Treatment for Acute ACL Tear (NCT NCT01692756)

NCT ID: NCT01692756

Last Updated: 2018-12-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 49 participants
• Primary outcome timeframe: Up to seven days
• Results posted on: 2018-12-05

Participant Flow

Participant milestones

Measure	Kenalog or Placebo Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then 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	Kenalog Only Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Overall Study STARTED	12	12	13	12
Overall Study COMPLETED	11	11	11	12
Overall Study NOT COMPLETED	1	1	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Treatment for Acute ACL Tear

Baseline characteristics by cohort

Measure	Kenalog or Placebo n=11 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=11 Participants 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	Kenalog Only n=11 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo	Total n=45 Participants Total of all reporting groups
Age, Continuous	18.45 years STANDARD_DEVIATION 2.99 • n=5 Participants	19.60 years STANDARD_DEVIATION 4.12 • n=7 Participants	24.06 years STANDARD_DEVIATION 6.57 • n=5 Participants	17.80 years STANDARD_DEVIATION 2.14 • n=4 Participants	19.9 years STANDARD_DEVIATION 4.8 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	26 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	38 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	11 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	45 Participants n=21 Participants
Knee Injury and Osteoarthritis Scale (KOOS) Pain Subscale	49.75 units on a scale STANDARD_DEVIATION 19.10 • n=5 Participants	58.33 units on a scale STANDARD_DEVIATION 15.42 • n=7 Participants	50.25 units on a scale STANDARD_DEVIATION 24.61 • n=5 Participants	46.30 units on a scale STANDARD_DEVIATION 25.02 • n=4 Participants	51.05 units on a scale STANDARD_DEVIATION 21.2 • n=21 Participants

PRIMARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=11 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=10 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Participant Pain Assessment	-3.9 units on a scale Standard Deviation 2.8	-2.2 units on a scale Standard Deviation 2.2	-3.6 units on a scale Standard Deviation 3.0	-4.3 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Up to seven days

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).

Outcome measures

Measure	Kenalog or Placebo n=11 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=11 Participants 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	Kenalog Only n=11 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Efficacy of Kenalog to Alleviate Knee Pain	37.37 units on a scale Standard Deviation 17.50	18.94 units on a scale Standard Deviation 11.02	30.56 units on a scale Standard Deviation 23.17	28.93 units on a scale Standard Deviation 22.36

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=9 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=9 Participants 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	Kenalog Only n=9 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Interleukin-1α (IL-1α) Concentration	4.30 pg/mL Standard Deviation 6.59	7.68 pg/mL Standard Deviation 13.15	1.77 pg/mL Standard Deviation 4.43	3.11 pg/mL Standard Deviation 5.03

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=9 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=9 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Interleukin-1β (IL-1β) Concentration	-1.08 pg/mL Standard Deviation 2.87	0.75 pg/mL Standard Deviation 1.98	-0.28 pg/mL Standard Deviation 0.37	-0.19 pg/mL Standard Deviation 0.29

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration	-3352.5 pg/mL Standard Deviation 8285.5	-4955.6 pg/mL Standard Deviation 12,939.6	-7278.4 pg/mL Standard Deviation 12,581.9	-6888.5 pg/mL Standard Deviation 8364.2

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial C-terminal Peptide II (CTXII) Concentration	0.32 ng/mL Standard Deviation 0.21	0.23 ng/mL Standard Deviation 0.27	0.19 ng/mL Standard Deviation 0.34	1.32 ng/mL Standard Deviation 1.10

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration	-4.9 μg/mL Standard Deviation 17.5	-21.7 μg/mL Standard Deviation 24.1	-11.7 μg/mL Standard Deviation 7.1	-22.1 μg/mL Standard Deviation 5.7

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Glycosaminoglycans (GAG) Concentration	-73.1 μg/mL Standard Deviation 176.7	155.8 μg/mL Standard Deviation 132.4	-49.0 μg/mL Standard Deviation 252.5	-167.4 μg/mL Standard Deviation 140.0

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration	3.5 µg/mL Standard Deviation 7.7	0.6 µg/mL Standard Deviation 4.0	2.6 µg/mL Standard Deviation 3.6	5.8 µg/mL Standard Deviation 6.5

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration	68.0 ng/ml Standard Deviation 266.0	57.6 ng/ml Standard Deviation 244.5	111.4 ng/ml Standard Deviation 180.5	-4.9 ng/ml Standard Deviation 224.0

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration	249.0 ng/mL Standard Deviation 745.9	-183.0 ng/mL Standard Deviation 245.5	-395.5 ng/mL Standard Deviation 472.2	-100.4 ng/mL Standard Deviation 557.9

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration	2702.9 ng/mL Standard Deviation 3937.2	504.0 ng/mL Standard Deviation 1705.9	-512.4 ng/mL Standard Deviation 2175.0	1295.9 ng/mL Standard Deviation 2414.3

SECONDARY outcome

Timeframe: Up to seven days

Population: 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.

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.

Outcome measures

Measure	Kenalog or Placebo n=10 Participants Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=10 Participants 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	Kenalog Only n=10 Participants Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 Participants subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration	-71.1 ng/mL Standard Deviation 15.9	-28.9 ng/mL Standard Deviation 42.6	-17.7 ng/mL Standard Deviation 18.8	-14.0 ng/mL Standard Deviation 24.5

Adverse Events

Kenalog or Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Kenalog Then Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Kenalog Only

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Kenalog or Placebo n=11 participants at risk Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Kenalog or placebo	Kenalog Then Placebo n=11 participants at risk 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	Kenalog Only n=11 participants at risk Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Kenalog	Placebo n=12 participants at risk subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Placebo
Gastrointestinal disorders Nausea or Hives/Rash from post op pain meds	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	8.3% 1/12 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
Musculoskeletal and connective tissue disorders ACL Re-Tear	36.4% 4/11 • Number of events 4 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	8.3% 1/12 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
General disorders Knee Effusion Post-Op	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	8.3% 1/12 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
General disorders Knee Effusion from Unanticipated Accident	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/12 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
General disorders Arthrofibrosis	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	18.2% 2/11 • Number of events 2 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/12 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
Musculoskeletal and connective tissue disorders Cervical Strain after Motor Vehicle Accident	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/12 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
General disorders Nosebleed	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	8.3% 1/12 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
Musculoskeletal and connective tissue disorders Infrapatella scarring/pain	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/12 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
General disorders Strep Throat	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	8.3% 1/12 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
General disorders Persistent Low Leg Pain	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/12 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.
General disorders Stitch Abscess	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	9.1% 1/11 • Number of events 1 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/11 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.	0.00% 0/12 • Over the course of 12months. Patients were approached and asked about any adverse events at regular study and/or clinic visits.

Additional Information

Cale Jacobs, ATC, PhD

Univerisity of Kentucky

Phone: 8592183065

Email: Kycartilagedoc@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place