Status:
COMPLETED
Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions
Lead Sponsor:
Cale Jacobs, PhD
Conditions:
Anterior Cruciate Ligament
Eligibility:
All Genders
14-33 years
Phase:
EARLY_PHASE1
Brief Summary
This research study is designed to allow the investigator to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. ...
Detailed Description
This is a single-center, placebo-controlled, double-blinded, randomized controlled trial. This trial will be conducted at the University of Kentucky's Orthopaedic and Sports Medicine Center (Turfland...
Eligibility Criteria
Inclusion
- 14-33 years of age
- Currently participating in a sporting activity
- ACL injury occurred while playing in a sporting activity
- Normal contralateral knee status
- Documentation of closed growth plates as noted on the screening x-rays
Exclusion
- Underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis etc)
- Currently have any infections, including infection of the skin, or have signs and symptoms of an infection, including fever
- 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
- Received corticosteroid injections into the injured knee within three months of enrollment
- History of allergic reaction to hyaluronan injections
- 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
Key Trial Info
Start Date :
April 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03429140
Start Date
April 6 2017
End Date
June 23 2019
Last Update
September 13 2022
Active Locations (1)
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1
UK Healthcare at Turfland
Lexington, Kentucky, United States, 40504