Clinical trial NCT05492851: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 6
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire
timeFrame: 6 month
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome
timeFrame: Baseline, 3 month, 6 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome
timeFrame: Baseline, 3 month, 6 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome
timeFrame: Baseline, 3 month, 6 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome
timeFrame: Baseline, 3 month, 6 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome
timeFrame: Baseline, 3 month
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Jameson Crane Sports Medicine Institute
state: Ohio
city: Lewis Center
country: United States
facility: Ohio State Outpatient Lewis Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Michael Baria
role: PRINCIPAL_INVESTIGATOR
References: