Trial Outcomes & Findings for Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury (NCT NCT04331002)
NCT ID: NCT04331002
Last Updated: 2023-07-27
Results Overview
Using manual segmentation, the volume of the medial femoral condyle will be quantified from 3-Tesla magnetic resonance imaging (MRI) scans performed before and 4 months after the study injection. Medial condyle volume will be expressed as cm3.
TERMINATED
PHASE2
1 participants
Baseline, 4 months
2023-07-27
Participant Flow
Participant milestones
| Measure |
Experimental
The experimental group will receive a single 32 mg Zilretta injection approximately 8 weeks after meniscus surgery.
Zilretta: ZILRETTA is an injectable suspension that delivers 32 mg of triamcinolone acetonide. It is supplied as a single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of 5 mL diluent, and one sterile vial adapter.
|
Placebo
The placebo group will receive a single 5 mL injection of normal saline approximately 8 weeks after meniscus surgery.
Placebo: 5 mL normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury
Baseline characteristics by cohort
| Measure |
Experimental
n=1 Participants
The experimental group will receive a single 32 mg Zilretta injection approximately 8 weeks after meniscus surgery.
Zilretta: ZILRETTA is an injectable suspension that delivers 32 mg of triamcinolone acetonide. It is supplied as a single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of 5 mL diluent, and one sterile vial adapter.
|
Placebo
The placebo group will receive a single 5 mL injection of normal saline approximately 8 weeks after meniscus surgery.
Placebo: 5 mL normal saline
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Height
|
66.96 inches
n=5 Participants
|
—
|
66.96 inches
n=5 Participants
|
|
Weight
|
169.75 pounds
n=5 Participants
|
—
|
169.75 pounds
n=5 Participants
|
|
Body Mass Index
|
26 kg/m2
n=5 Participants
|
—
|
26 kg/m2
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 monthsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
Using manual segmentation, the volume of the medial femoral condyle will be quantified from 3-Tesla magnetic resonance imaging (MRI) scans performed before and 4 months after the study injection. Medial condyle volume will be expressed as cm3.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The International Knee Documentation Committee (IKDC) scores range from 0-100 with greater scores being indicative of greater self-reported function and reduced pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The Knee injury and Osteoarthritis Outcome Score (KOOS) Global scores range from 0-100 with greater scores being indicative of greater self-reported knee function and reduced pain and symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 months, 1 year, 2 yearsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
The Intermittent and Constant Osteoarthritis Pain (ICOAP) Score is a valid and reliable tool to assess osteoarthritis-related pain. Scores range from 0 to 100, with greater scores indicating worse pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 4 monthsPopulation: One participant was enrolled in this study. Due to the possibility that the participant could reasonably be identified due to low enrollment, data cannot be presented.
C-terminal cross-linked telopeptides (CTX); CTXII levels measured by ELISA. CTXII is a biomarker of type II collagen breakdown
Outcome measures
Outcome data not reported
Adverse Events
Experimental
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place