Anterior Cruciate Ligament (ACL) Tears
Conditions
Brief summary
This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University. The purpose of this research is to gather information on how safe and effective Kenalog® is in alleviating knee pain following ACL rupture.
Detailed description
Injury to the knee during sports participation often involves partial of full detachment of the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood. In this research study, we hope to prevent and reduce the initial post-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL injuries by treating them within 1-2 days after their injury.
Interventions
Sponsors
Vanderbilt University
Cale Jacobs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 33 Years
Healthy volunteers
No
Inclusion criteria
* currently participating in sporting activities * Normal contralateral knee status * Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity
Exclusion criteria
* underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.) * have been diagnosed with hepatitis B or tuberculosis * currently have an infection, including infection of the skin * have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs * other major medical condition requiring treatment with immunosuppressant or modulating drugs. * A history of chronic use of non-steroidal anti-inflammatory drugs * previous exposure or allergic reaction to Kenalog * prior knee surgery (Ipsilateral or contralateral) * have received any investigational drug with 4 weeks of study Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Pain Assessment | Up to seven days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Synovial Interleukin-1α (IL-1α) Concentration | Up to seven days | 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. |
| Synovial Interleukin-1β (IL-1β) Concentration | Up to seven days | 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. |
| Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration | Up to seven days | 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. |
| Synovial C-terminal Peptide II (CTXII) Concentration | Up to seven days | 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. |
| Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration | Up to seven days | 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. |
| Efficacy of Kenalog to Alleviate Knee Pain | 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). |
| Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration | Up to seven days | 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. |
| Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration | Up to seven days | 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. |
| Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration | Up to seven days | 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. |
| Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration | Up to seven days | 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. |
| Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration | Up to seven days | 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. |
| Synovial Glycosaminoglycans (GAG) Concentration | Up to seven days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kenalog or Placebo Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later.
Kenalog or placebo | 11 |
| 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 | 11 |
| Kenalog Only Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog®
Kenalog | 11 |
| Placebo subjects will receive two consecutive intra-articular saline placebo injections at the same time periods.
Placebo | 12 |
| Total | 45 |
Baseline characteristics
| Characteristic | Kenalog or Placebo | Kenalog Then Placebo | Kenalog Only | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 18.45 years STANDARD_DEVIATION 2.99 | 19.60 years STANDARD_DEVIATION 4.12 | 24.06 years STANDARD_DEVIATION 6.57 | 17.80 years STANDARD_DEVIATION 2.14 | 19.9 years STANDARD_DEVIATION 4.8 |
| Knee Injury and Osteoarthritis Scale (KOOS) Pain Subscale | 49.75 units on a scale STANDARD_DEVIATION 19.1 | 58.33 units on a scale STANDARD_DEVIATION 15.42 | 50.25 units on a scale STANDARD_DEVIATION 24.61 | 46.30 units on a scale STANDARD_DEVIATION 25.02 | 51.05 units on a scale STANDARD_DEVIATION 21.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 10 Participants | 8 Participants | 38 Participants |
| Region of Enrollment United States | 11 Participants | 11 Participants | 11 Participants | 12 Participants | 45 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 5 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 6 Participants | 5 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 7 / 11 | 4 / 11 | 6 / 11 | 5 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 |
Outcome results
Primary
Participant Pain Assessment
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Participant Pain Assessment | -3.9 units on a scale | Standard Deviation 2.8 |
| Kenalog Then Placebo | Participant Pain Assessment | -2.2 units on a scale | Standard Deviation 2.2 |
| Kenalog Only | Participant Pain Assessment | -3.6 units on a scale | Standard Deviation 3 |
| Placebo | Participant Pain Assessment | -4.3 units on a scale | Standard Deviation 3.2 |
p-value: 0.33Kruskal-Wallis
Secondary
Efficacy of Kenalog to Alleviate Knee Pain
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Efficacy of Kenalog to Alleviate Knee Pain | 37.37 units on a scale | Standard Deviation 17.5 |
| Kenalog Then Placebo | Efficacy of Kenalog to Alleviate Knee Pain | 18.94 units on a scale | Standard Deviation 11.02 |
| Kenalog Only | Efficacy of Kenalog to Alleviate Knee Pain | 30.56 units on a scale | Standard Deviation 23.17 |
| Placebo | Efficacy of Kenalog to Alleviate Knee Pain | 28.93 units on a scale | Standard Deviation 22.36 |
p-value: 0.08Kruskal-Wallis
Secondary
Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration | -4.9 μg/mL | Standard Deviation 17.5 |
| Kenalog Then Placebo | Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration | -21.7 μg/mL | Standard Deviation 24.1 |
| Kenalog Only | Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration | -11.7 μg/mL | Standard Deviation 7.1 |
| Placebo | Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration | -22.1 μg/mL | Standard Deviation 5.7 |
p-value: 0.007Kruskal-Wallis
Secondary
Synovial C-terminal Peptide II (CTXII) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial C-terminal Peptide II (CTXII) Concentration | 0.32 ng/mL | Standard Deviation 0.21 |
| Kenalog Then Placebo | Synovial C-terminal Peptide II (CTXII) Concentration | 0.23 ng/mL | Standard Deviation 0.27 |
| Kenalog Only | Synovial C-terminal Peptide II (CTXII) Concentration | 0.19 ng/mL | Standard Deviation 0.34 |
| Placebo | Synovial C-terminal Peptide II (CTXII) Concentration | 1.32 ng/mL | Standard Deviation 1.1 |
p-value: 0.003Kruskal-Wallis
Secondary
Synovial Glycosaminoglycans (GAG) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Glycosaminoglycans (GAG) Concentration | -73.1 μg/mL | Standard Deviation 176.7 |
| Kenalog Then Placebo | Synovial Glycosaminoglycans (GAG) Concentration | 155.8 μg/mL | Standard Deviation 132.4 |
| Kenalog Only | Synovial Glycosaminoglycans (GAG) Concentration | -49.0 μg/mL | Standard Deviation 252.5 |
| Placebo | Synovial Glycosaminoglycans (GAG) Concentration | -167.4 μg/mL | Standard Deviation 140 |
p-value: 0.63Kruskal-Wallis
Secondary
Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration | -3352.5 pg/mL | Standard Deviation 8285.5 |
| Kenalog Then Placebo | Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration | -4955.6 pg/mL | — |
| Kenalog Only | Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration | -7278.4 pg/mL | — |
| Placebo | Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration | -6888.5 pg/mL | Standard Deviation 8364.2 |
p-value: 0.15Kruskal-Wallis
Secondary
Synovial Interleukin-1α (IL-1α) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Interleukin-1α (IL-1α) Concentration | 4.30 pg/mL | Standard Deviation 6.59 |
| Kenalog Then Placebo | Synovial Interleukin-1α (IL-1α) Concentration | 7.68 pg/mL | Standard Deviation 13.15 |
| Kenalog Only | Synovial Interleukin-1α (IL-1α) Concentration | 1.77 pg/mL | Standard Deviation 4.43 |
| Placebo | Synovial Interleukin-1α (IL-1α) Concentration | 3.11 pg/mL | Standard Deviation 5.03 |
p-value: 0.93Kruskal-Wallis
Secondary
Synovial Interleukin-1β (IL-1β) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Interleukin-1β (IL-1β) Concentration | -1.08 pg/mL | Standard Deviation 2.87 |
| Kenalog Then Placebo | Synovial Interleukin-1β (IL-1β) Concentration | 0.75 pg/mL | Standard Deviation 1.98 |
| Kenalog Only | Synovial Interleukin-1β (IL-1β) Concentration | -0.28 pg/mL | Standard Deviation 0.37 |
| Placebo | Synovial Interleukin-1β (IL-1β) Concentration | -0.19 pg/mL | Standard Deviation 0.29 |
p-value: 0.13Kruskal-Wallis
Secondary
Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration | 249.0 ng/mL | Standard Deviation 745.9 |
| Kenalog Then Placebo | Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration | -183.0 ng/mL | Standard Deviation 245.5 |
| Kenalog Only | Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration | -395.5 ng/mL | Standard Deviation 472.2 |
| Placebo | Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration | -100.4 ng/mL | Standard Deviation 557.9 |
p-value: 0.02Kruskal-Wallis
Secondary
Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration | 2702.9 ng/mL | Standard Deviation 3937.2 |
| Kenalog Then Placebo | Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration | 504.0 ng/mL | Standard Deviation 1705.9 |
| Kenalog Only | Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration | -512.4 ng/mL | Standard Deviation 2175 |
| Placebo | Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration | 1295.9 ng/mL | Standard Deviation 2414.3 |
p-value: 0.2Kruskal-Wallis
Secondary
Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration | -71.1 ng/mL | Standard Deviation 15.9 |
| Kenalog Then Placebo | Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration | -28.9 ng/mL | Standard Deviation 42.6 |
| Kenalog Only | Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration | -17.7 ng/mL | Standard Deviation 18.8 |
| Placebo | Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration | -14.0 ng/mL | Standard Deviation 24.5 |
p-value: 0.87Kruskal-Wallis
Secondary
Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration | 68.0 ng/ml | Standard Deviation 266 |
| Kenalog Then Placebo | Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration | 57.6 ng/ml | Standard Deviation 244.5 |
| Kenalog Only | Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration | 111.4 ng/ml | Standard Deviation 180.5 |
| Placebo | Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration | -4.9 ng/ml | Standard Deviation 224 |
p-value: 0.62Kruskal-Wallis
Secondary
Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kenalog or Placebo | Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration | 3.5 µg/mL | Standard Deviation 7.7 |
| Kenalog Then Placebo | Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration | 0.6 µg/mL | Standard Deviation 4 |
| Kenalog Only | Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration | 2.6 µg/mL | Standard Deviation 3.6 |
| Placebo | Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration | 5.8 µg/mL | Standard Deviation 6.5 |
p-value: 0.17Kruskal-Wallis