Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05492851
• Other study ID #: 2022H0168
• Status: Terminated
• Phase: Phase 4
• Start date: August 2, 2022
• Est. completion date: January 11, 2023

Study information

• Verified date: April 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.

Description:

Knee osteoarthritis (OA) is a leading cause of disability worldwide.1,2 Standard of care treatments for knee OA include activity modification, weight loss, therapeutic exercise and medications like non-steroidal anti-inflammatory drugs (NSAIDs). If these measures fail, injections like corticosteroids and hyaluronate (HA) can be helpful for pain control.3 The aforementioned injections have unique mechanisms of action. Steroid injections work through reducing joint inflammation, while HA works by lubricating and cushioning the joint. There are several varieties of steroids and HA injections that have been approved by the Food and Drug Administration for use in knee OA. Among these variations are extended-release triamcinolone (Zilretta), hylan GF-20 (synvisc one), and hyaluronan (monovisc). While each are FDA approved and commonly used in orthopedic and sports medicine clinics, they have never been directly compared in any study. Therefore, when selecting a treatment for a patient, it is largely based on provider preference, not clinical data. This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age 25-85 years
• BMI < 40
• Diagnosis of unilateral knee OA
• Radiographic evidence of OA of the target knee (Kellgren-Lawrence grades 2-4)
• Continued OA pain in the target knee despite at least 6 weeks of: physical therapy and at least one of the following: activity modification (such as reducing impact on the knee), weight loss, and a 2 week trial of NSAID / acetaminophen.
• Knee Osteoarthritis Outcomes Score (KOOS)-Pain subscale 20-65
• Working knowledge of English language (to be able to complete all outcome scores)
• Ability to attend all follow-up appointments

Exclusion Criteria:

• 3+ effusion of the target knee (stroke test grading system)
• Prior injection therapy:
• Steroid injection in target knee in the last 3 months
• Viscosupplementation in target knee in the last 6 months
• PRP in the target knee in the last 6 months
• Cellular treatments in index knee (bone marrow, amniotic suspensions etc) 1 year
• Participation in any experimental device or drug study within 1 year before screening visit
• Oral or IM steroids in the last 3 months (Inhaled steroids used in the treatment of asthma/allergies are permitted)
• Medical condition that may impact outcomes of procedure including:
• Systemic inflammatory disorders that impact the joints like rheumatoid arthritis, lupus, etc
• Undergoing current cancer treatment (other than non-melanoma skin malignancies)
• Taking immunosuppressants
• Previous cartilage repair procedure on the injured cartilage surface (ie, OATS, ACI, MFX) in the last 5 years
• Previous surgery at the target knee within the past 1 year
• Any degree of cognitive impairment
• Symptomatic OA of any other joint in the lower limbs
• Pregnancy, lactating, or intent to become pregnant during treatment period (Female participants will be asked if they are pregnant, lactating, or intend to become pregnant during treatment)
• Gout, Pseudogout (including radiographic evidence of chondrocalcinosis)
• History of infection or current infection at the affected joint
• Smoking (Former smokers< 1 year from quit date)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Zilretta
Intra-articular injection to treat knee osteoarthritis
• Synvisc-One 48 MG in 6 ML Prefilled Syringe
Intra-articular injection to treat knee osteoarthritis
• Monovisc 88 MG Per 4 ML Prefilled Syringe
Intra-articular injection to treat knee osteoarthritis

Locations

Country	Name	City	State
United States	Jameson Crane Sports Medicine Institute	Columbus	Ohio
United States	Ohio State Outpatient Lewis Center	Lewis Center	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire	KOOS Pain evaluates short-term and long-term pain in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee pain.	6 month
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome	KOOS symptoms evaluates short-term and long-term symptoms in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee symptoms.	Baseline, 3 month, 6 month
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome	KOOS ADL evaluates short-term and long-term function in daily living in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to daily living activity.	Baseline, 3 month, 6 month
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome	KOOS Sport/Rec evaluates short-term and long-term function in sports and recreation in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to sports or recreation activity.	Baseline, 3 month, 6 month
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome	KOOS QOL evaluates short-term and long-term knee quality of life in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to quality of life.	Baseline, 3 month, 6 month
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome	KOOS Pain evaluates short-term and long-term pain in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee pain.	Baseline, 3 month