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Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zilretta
Synvisc-One 48 MG in 6 ML Prefilled Syringe
Monovisc 88 MG Per 4 ML Prefilled Syringe
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jameson Crane Sports Medicine Institute
  • Ohio State Outpatient Lewis Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Zilretta

Synvisc One

Monovisc

Arm Description

Generic Name: Triamcinolone acetonide Zilretta is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management ofosteoarthritis pain of the knee. 5mL suspension of 32 mg of triamsinolone administered as a 1 dose parapatellar intra-articular injection.

Generic Name: Hylan G-F 20 Synvisc-One combines the three doses of SYNVISC (hylan G-F 20) which consists of hylan A (average molecular weight6,000,000 daltons) and hylan B hydrated gel in a buffered physiological sodium chloride solution, pH 7.2. Each 10 mL syringe of Synvisc-One combines the three 2-mL doses (16 mg each) of a complete SYNVISC treatment regimen (48 mg). Synvisc-One belongs to a class of drugs called Intra-Articular Agents; Rheumatologics, Other. 10mL of Hylan G-F 20 administered as a 1 dose parapatellar intra-articular injection.

Generic Name: Hyaluronan The Monovisc™ device is a proprietary high molecular weight hyaluronic acid (HA) viscosupplementation intended for the treatment of pain in patients with moderate osteoarthritis (OA) of the knee who have failed conservative non-pharmacological therapy and simple analgesics. The device is administered by a single injection via the para-patellar approach under sterile conditions. 4mL injection of Hyaluronan administered as a 1 dose parapatellar intra-articular injection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 4, 2022
Last Updated
April 6, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05492851
Brief Title
Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
Official Title
A Double-blind, Randomized Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
The study has only enrolled 6 subjects in 6 months since study initiation. Potential participants are unwilling to participate in the study due to the randomziation and blinding. Both aspects are needed to ensure a robust comparison between groups.
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
January 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zilretta
Arm Type
Active Comparator
Arm Description
Generic Name: Triamcinolone acetonide Zilretta is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management ofosteoarthritis pain of the knee. 5mL suspension of 32 mg of triamsinolone administered as a 1 dose parapatellar intra-articular injection.
Arm Title
Synvisc One
Arm Type
Active Comparator
Arm Description
Generic Name: Hylan G-F 20 Synvisc-One combines the three doses of SYNVISC (hylan G-F 20) which consists of hylan A (average molecular weight6,000,000 daltons) and hylan B hydrated gel in a buffered physiological sodium chloride solution, pH 7.2. Each 10 mL syringe of Synvisc-One combines the three 2-mL doses (16 mg each) of a complete SYNVISC treatment regimen (48 mg). Synvisc-One belongs to a class of drugs called Intra-Articular Agents; Rheumatologics, Other. 10mL of Hylan G-F 20 administered as a 1 dose parapatellar intra-articular injection.
Arm Title
Monovisc
Arm Type
Active Comparator
Arm Description
Generic Name: Hyaluronan The Monovisc™ device is a proprietary high molecular weight hyaluronic acid (HA) viscosupplementation intended for the treatment of pain in patients with moderate osteoarthritis (OA) of the knee who have failed conservative non-pharmacological therapy and simple analgesics. The device is administered by a single injection via the para-patellar approach under sterile conditions. 4mL injection of Hyaluronan administered as a 1 dose parapatellar intra-articular injection.
Intervention Type
Drug
Intervention Name(s)
Zilretta
Intervention Description
Intra-articular injection to treat knee osteoarthritis
Intervention Type
Drug
Intervention Name(s)
Synvisc-One 48 MG in 6 ML Prefilled Syringe
Intervention Description
Intra-articular injection to treat knee osteoarthritis
Intervention Type
Drug
Intervention Name(s)
Monovisc 88 MG Per 4 ML Prefilled Syringe
Intervention Description
Intra-articular injection to treat knee osteoarthritis
Primary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire
Description
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.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome
Description
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.
Time Frame
Baseline, 3 month, 6 month
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome
Description
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.
Time Frame
Baseline, 3 month, 6 month
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome
Description
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.
Time Frame
Baseline, 3 month, 6 month
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome
Description
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.
Time Frame
Baseline, 3 month, 6 month
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome
Description
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.
Time Frame
Baseline, 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Baria
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jameson Crane Sports Medicine Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Ohio State Outpatient Lewis Center
City
Lewis Center
State/Province
Ohio
ZIP/Postal Code
43035
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IDP will not be shared.

Learn more about this trial

Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

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