Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

The purpose of this research is to gather information on how safe and effective Gel-One is in alleviating knee pain following ACL surgery.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cale Jacobs, PhD; Mary Ireland
• Treatments: Anti-Inflammatory Agents; Hyaluronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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