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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament
• Intervention / Treatment: Drug: Gel-One; Other: Saline Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • UK Healthcare at Turfland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 33 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRIT1rho measurement of articular cartilage	MRI measurement	12 months
Number of participants with adverse events that are related to treatment.	Protocol safety questionnaires and SAE/AE reporting	12 months

Collaborators and Investigators

• Sponsor: Cale Jacobs, PhD

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2017
• Primary Completion (Actual): June 23, 2019
• Study Completion (Actual): June 23, 2019

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 16-0662-F6A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No