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

NCT03429140 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-09-13

No results posted yet for this study

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

Interventions

DRUG

Gel-One

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

OTHER

Saline Placebo

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

Sponsors & Collaborators

  • Cale Jacobs, PhD

    lead OTHER

Principal Investigators

  • Cale Jacobs, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
33 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2019-06-23
Completion
2019-06-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03429140 on ClinicalTrials.gov