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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Facility), with subjects being recruited from the patient populations of UK's Sports Medicine surgeons (Drs. Christian Lattermann, Darren Johnson, Mary Lloyd Ireland, and Scott Mair) during regularly schedule office visits. After providing informed consent, subjects will be randomized into one of two groups, and there will be 19 subjects per group. All groups will receive standard of care aspiration and triamcinolone injection (40mg, Kenalog) within 1-10 days after ACL injury. The subjects will undergo initial standard of care pre-habilitation as deemed necessary by the surgeon and will undergo ACL reconstruction surgery. Knee aspiration will be performed 7-10 days after ACL reconstruction surgery and the patients will be randomized into 1 of 2 groups: Group 1: will receive injection of Gel-One (3ml 30mg Hyaluronan) Group 2: will receive an injection of 3ml of a saline placebo Knee Aspiration: All subjects will undergo a total of four aspirations. Visit Schedule and Procedures: Visit 1 Screening (1-10 days post injury): Upon arriving at the clinic potential subjects will have the following assessments: range of motion, knee instability (Lachman's test) and standardized Flexion weight bearing x-rays, all of which are the standard of care for a patient with a suspected ACL injury. After providing informed consent to participate in the study, subjects will be asked to fill in standard questionnaires. Collection of urine and 10 cc of blood for laboratory testing, partial Medical history, concomitant medications, demographic information, body mass index (BMI) measurement, smoking status, and questions will be collected. Scheduling for study-related magnet resonance imaging (MRI) scans. Visit 2 (day of surgery) Lab specimens collected (urine and 10cc of blood) Pain Questionnaires administered prior to surgery Knee aspiration (in the operating room under anesthesia, both knees) Patient reported outcomes (PROs) administered prior to surgery Visit 3 (1-2 weeks post surgery) Pain Questionnaires administered Lab tests (urine and 10cc of blood) Randomization into group 1 or 2 Knee aspiration and administration of either 3ml of saline(placebo) or Hyaluronan (study drug) Visit 4 (4-6 weeks post surgery) Pain Questionnaire administered Knee aspiration and lab specimens collected Patient reported outcomes (PROs) administered Visit 5 (6 months follow-up/Early Termination Visit) Patient reported outcomes (PROs) administered Pain Questionnaires administered Functional laboratory testing Visit 6 (12 months follow-up/Early Termination Visit) Patient reported outcomes (PROs) administered Pain Questionnaires administered Functional laboratory testing MRI scan There are no costs associated with either the study medications and study-specific laboratory and imaging analyses. Either the participant or their insurance company, Medicare or Medicaid will be responsible for the costs of all care and treatment a participant receives during this study that they would normally receive for their condition. These are costs that are considered medically reasonable and necessary and will be part of the care a patient would receive if they did not take part in this study.

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

Conditions
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Anterior Cruciate Ligament

Intervention / Treatment
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* Drug: Gel-One
* Other: Saline Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Gel-One<br>Gel-One (3ml/30 mg Hyaluronan) one time injection at visit 3 | Drug: Gel-One<br>* an injection of Gel-One® (hyaluronan, 3 mL) 1-2 weeks after ACL surgery<br>|
| Placebo Comparator: Group 1 - Saline Placebo<br>3 ml saline placebo one time injection at visit 3 | Other: Saline Placebo<br>* a placebo injection (saline, 3 mL) 1-2 weeks after ACL surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in KOOS score over time | Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CTX-II pre and post surgery | CTX -II ELISA measurements | up to 4 weeks |