Trial Comparing Three Single Dose Injections for Knee Osteoarthritis

NCT05492851 | Terminated Phase 4 FDA Drug

• 1 other identifier: 2022H0168
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome

  Baseline, 3 month, 6 month

• Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome

  Baseline, 3 month, 6 month

• Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome

  Baseline, 3 month, 6 month

• Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome

  Baseline, 3 month, 6 month

• Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome

  Baseline, 3 month

Study Arms (3)

Zilretta

ACTIVE COMPARATOR

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.

Drug: Zilretta

Synvisc One

ACTIVE COMPARATOR

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.

Drug: Synvisc-One 48 MG in 6 ML Prefilled Syringe

Monovisc

ACTIVE COMPARATOR

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.

Drug: Monovisc 88 MG Per 4 ML Prefilled Syringe

Interventions

Zilretta DRUG

Intra-articular injection to treat knee osteoarthritis

Zilretta

Synvisc-One 48 MG in 6 ML Prefilled Syringe DRUG

Intra-articular injection to treat knee osteoarthritis

Synvisc One

Monovisc 88 MG Per 4 ML Prefilled Syringe DRUG

Intra-articular injection to treat knee osteoarthritis

Monovisc

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• + 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (2)

Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location

Ohio State Outpatient Lewis Center

Lewis Center, Ohio, 43035, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Triamcinolone; hylan; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Michael Baria

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 9, 2022
• Study Start: August 2, 2022
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)