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

NCT03429140 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 16-0662-F6A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

• Change in KOOS score over time

  Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms

  12 months

Secondary Outcomes (1)

• Change in CTX-II pre and post surgery

  up to 4 weeks

Other Outcomes (2)

• MRIT1rho measurement of articular cartilage

  12 months

• Number of participants with adverse events that are related to treatment.

  12 months

Study Arms (2)

Group 1 - Gel-One

EXPERIMENTAL

Gel-One (3ml/30 mg Hyaluronan) one time injection at visit 3

Drug: Gel-One

Group 1 - Saline Placebo

PLACEBO COMPARATOR

3 ml saline placebo one time injection at visit 3

Other: Saline Placebo

Interventions

Gel-One DRUG

an injection of Gel-One® (hyaluronan, 3 mL) 1-2 weeks after ACL surgery

Group 1 - Gel-One

Saline Placebo OTHER

a placebo injection (saline, 3 mL) 1-2 weeks after ACL surgery

Group 1 - Saline Placebo

Eligibility Criteria

• Age: 14 Years - 33 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cale Jacobs, PhD: lead

Study Sites (1)

UK Healthcare at Turfland

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Cale Jacobs, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Once it has been determined that a subject meets the entry requirements of the study they will be randomized, like the flipping of coin into one of two treatment groups. Neither the subject nor the investigator will be told which of the two treatments that the subject is assigned to. However, the investigator can find out in the case of emergency. Treatment assignment will be released to the subject after they have completed all study visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 12, 2018
• Study Start: April 6, 2017
• Primary Completion: June 23, 2019
• Study Completion: June 23, 2019
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)