Trial Outcomes & Findings for Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain (NCT NCT02892500)
NCT ID: NCT02892500
Last Updated: 2024-02-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
One year
Results posted on
2024-02-13
Participant Flow
No participants were randomized or treated during the study.
Participant milestones
| Measure |
Bupivacaine Hydrochloride and Betamethasone Sodium Phosphate
When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed the area will be injected with a mixture of 5 ml of 0.25 % bupivacaine hydrochloride and 2 ml of 3 mg/ml betamethasone sodium phosphate (Celestone® Soluspan®) (BTM)
bupivacaine hydrochloride and betamethasone sodium phosphate: 5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament
|
Bupivacaine Hydrochloride
When the patient has been randomized to either group, a licensed provider under the direction of the PI, will utilize the ultrasound to identify the inferior tibiofibular ligament (syndesmotic ligament). This provider that performs the injection will not be involved in any follow-up visits or return to play review. When appropriate positioning is confirmed, the area will be injected with 5ml of bupivacaine hydrochloride.
bupivacaine hydrochloride: 5ml of bupivacaine hydrochloride into the tibiofibular ligament
|
|---|---|---|
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
|
0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: One yearPopulation: No participants randomized and treated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One yearPopulation: No participants randomized or treated.
Outcome measures
Outcome data not reported
Adverse Events
Bupivacaine Hydrochloride and Betamethasone Sodium Phosphate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine Hydrochloride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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