Effect of Zilretta Injection

Status Completed

Clinical Trial Summary

The purpose of this study is to examine the pre-post effects of a single ZILRETTA knee injection on physiological measures of self-reported pain and disability, physical performance, and physical activity in individuals with knee osteoarthritis (OA). The investigators will recruit 35 symptomatic knee OA patients for this study. All data will be collected prior to injection (baseline), as well as at 4 (post 1) and 8-week follow-ups (post 2).

Clinical Trial Description

Individuals with knee osteoarthritis (OA) demonstrate significant physical disability which leads to diminished physical activity, a lesser quality of life, as well as a higher risk of inactivity related comorbidities including mortality. This is thought to be caused by an inability to voluntarily activate your quadriceps muscle due, in part, to knee joint swelling and joint-related pain. Incomplete muscle activation causes quadriceps weakness. Individuals with quadriceps weakness exhibit changes in their walking biomechanics which is associated with diminished physical function and lesser physical activity in those with knee OA. Therefore, it is critical to develop interventions that target mechanisms causing decreased quadriceps activation in order to restore optimal walking biomechanics and improve physical activity. The ZILRETTA knee injection is an FDA approved, extended release corticosteroid for in patients with knee osteoarthritis and has been shown to reduced knee pain for 3 months in approximately 70% of patients. Currently, there are no studies that have examined ZILRETTA's objective effectiveness on physical activity, biomechanics, and performance tests in patients who have received an injection. The overall purpose of the current study is to examine the effect of a ZILRETTA knee injection on functional and performance tests including quadriceps neuromuscular activation, quadriceps strength, walking gait biomechanics, and a battery of physical performance outcomes at 4 and 8-weeks following injection in 35 individuals with knee OA. ;

Study Design

Related Conditions & MeSH terms

Osteoarthritis, Knee

Clinical Trial Details

NCT number	NCT04261049
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	Phase 1
Start date	August 1, 2020
Completion date	January 10, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03895489` - Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses	N/A
Completed	`NCT03660943` - A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain	Phase 3
Completed	`NCT04531969` - Comparison of Outpatient and Inpatient Spa Therapy	N/A
Completed	`NCT02848027` - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment	Phase 3
Completed	`NCT05160246` - The Instant Effect of Kinesiology Taping in Patients With Knee OA	N/A
Recruiting	`NCT06080763` - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed	`NCT03643588` - The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain	N/A
Active, not recruiting	`NCT05100225` - Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis	Phase 2
Active, not recruiting	`NCT04061733` - New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis	N/A
Completed	`NCT04051489` - A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Recruiting	`NCT05546541` - Epidemiology and Nutrition
Recruiting	`NCT05447767` - Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg	Phase 2
Not yet recruiting	`NCT04448106` - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis	Phase 2
Not yet recruiting	`NCT03225911` - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis	N/A
Completed	`NCT05070871` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women	N/A
Completed	`NCT05703087` - Positive Cueing in Knee Arthroplasty.	N/A
Not yet recruiting	`NCT06042426` - Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population	Phase 4
Not yet recruiting	`NCT02865174` - Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty	Phase 4
Completed	`NCT03037489` - A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients	Phase 2
Terminated	`NCT02909257` - Motor-Sparing Femoral Nerve Block Dose	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.