TerminatedPhase 2

IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions

Stopped: Lack of funding

United States6 participantsStarted 2019-06-20

Plain-language summary

Injury to the knee during sports participation often involves partial or full detachment of the anterior cruciate ligament (abbreviated as 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, the investigator hopes to reduce the initial pre-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. The investigator is interested to see if the use of Kineret does decrease the risk of developing arthritis in individuals with ACL injuries by treating them within 28 days after their injury.

Who can participate

Age range

14 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Acute ACL Tear and Painful Effusions * Signed and dated combined informed consent/HIPAA form and if a minor, a signed assent. * Willingness to comply with all study procedures and availability for the duration of the study * For females of reproductive potential: use of highly effective contraception. * Currently participating in a sporting activity * Documentation of closed growth plates as noted on the screening x-ray Exclusion Criteria: * underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis etc) * have been diagnosed with hepatitis B or tuberculosis * currently have an infections, including infection of the skin, or have signs and symptoms of an infection, including fever. * any abnormalities in their white blood cell counts * 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 * Currently taking immunosuppressant medication, including oral and parenteral corticosteroids (topical and stable dose inhaled corticosteriods are acceptable) * Females who are pregnant or breastfeeding * Received a "live" vaccine (smallpox, MMR (measles, mumps and rubella), flu, polio, typhoid, chicken pox, yellow fever, herpes zoster) 4 weeks prior to screening. * A history of bleeding disorders or are taking any blood thinning medications, aspirin or …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptom Score Between Groups

Timeframe: 1 year

Trial details

NCT IDNCT02930122

SponsorCale Jacobs, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-16

Results submitted2021-10-04

View on ClinicalTrials.gov More Anterior Cruciate Ligament Tear trials