Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions
Condition: Anterior Cruciate Ligament
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional
Phase: Early Phase 1

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.
    

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 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.
    

Intervention name(s): Gel-One; Saline Placebo
Intervention type(s): Drug; Other
Intervention description(s): an injection of Gel-One® (hyaluronan, 3 mL) 1-2 weeks after ACL surgery; a placebo injection (saline, 3 mL) 1-2 weeks after ACL surgery
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment