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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02930122
Recruitment Status : Terminated (Lack of funding)
First Posted : October 12, 2016
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Cale Jacobs, PhD, University of Kentucky

Brief 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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Tear Drug: anakinra (150mg) Other: Saline intraarticularly Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Single-Center, Randomized, Triple-Blinded, Placebo-Controlled Study of IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : October 16, 2020
Actual Study Completion Date : October 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Anakinra

Arm Intervention/treatment
Experimental: Arm 1
Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury
Drug: anakinra (150mg)
intraarticular administration
Other Name: Kineret

Placebo Comparator: Placebo Control
Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury
Other: Saline intraarticularly
intraarticular administration
Other Name: Saline (0.9%)




Primary Outcome Measures :
  1. Change of KOOS symptom score between groups [ Time Frame: 1 year ]
    KOOS symptoms score


Secondary Outcome Measures :
  1. Change in CTX-II levels from injury to time of surgery [ Time Frame: time of surgery ]
    CTX-II levels measured by ELISA


Other Outcome Measures:
  1. MRI T1rho Changes [ Time Frame: 1 year ]
    MRI: T1rho values in Medial and lateral femoral condyle as wel as medial and lateral tibial plateau

  2. Change in KOOS QOL score between groups [ Time Frame: 1 year ]
    KOOS QOL



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 other medications affecting blood clotting.
  • Previous exposure or allergic reaction to anakinra
  • Allergy to latex or tape
  • Allergy to Kineret or have had a reaction to any local or general anesthesia
  • prior knee surgery (contralateral)
  • have received any investigational drug with 4 weeks of study Visit 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930122


Locations
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United States, Kentucky
UK Healthcare at Turfland
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
Cale Jacobs, PhD
Investigators
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Study Chair: Austin Stone, MD University of Kentucky
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Responsible Party: Cale Jacobs, PhD, Assistant Professor Research, University of Kentucky
ClinicalTrials.gov Identifier: NCT02930122    
Other Study ID Numbers: 45595
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents