Overview

Effect of ZILRETTA Versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance

Status:
Completed
Trial end date:
2021-04-28
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to examine the pre, post, and follow up effects of a single ZILRETTA knee injection vs a single CELESTONE SOLUSPAN knee injection on physiological measure of self-reported quality of life, pain, physical function, and physical performance in individuals with osteoarthritis (OA) knee pain. The Primary Investigator (PI) will recruit 20 symptomatic knee OA patients for this study. Patients will be randomized into one of two treatment arms, Arm 1 (ZILRETTA injection) or Arm 2 (CELESTONE SOLUSPAN injection). Patients in Arm 1 will receive a single 5 mL IV injection of 32 mg ZILRETTA into the affected knee joint. Patients in Arm 2 will receive a 5ml IV injection of 6mg/ml CELESTONE SOLUSPAN into the affected knee joint. Each study arm will include 10 patients. All data will be collected prior to injection (baseline), as well as at 6-week (post 1) and 12-week follow-ups (post 2). Patients will blinded to treatment arm until after they complete their 12-week follow up.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ROC Foundation
Treatments:
Betamethasone
Betamethasone acetate
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Criteria
Inclusion Criteria

- Men and women age 18 years or older with symptomatic bilateral knee OA

- Symptomatic knee OA will be defined as the presence of a definite osteophyte or joint
space narrowing (KL Grade ≥2) on posteroanterior (PA) fixed flexion knee radiographs
in subjects limited by bilateral pain rated on a Numerical Rating Scale as ≥ 4/10 on
more than half of the days over the past month. Radiographic change must be visible at
standard image size, irrespective of capability to detect more subtle changes through
digital enhancement.

- Bilateral knee symptoms for ≥ 3 months prior to screening

- Has undergone at least one prior conservative osteoarthritis treatment (e.g. Physical
therapy, analgesics)

- Ambulatory

- Willing and able to comply with the study procedures and visit schedules and ability
to follow verbal and written instructions.

Exclusion Criteria

- Current consumption of more than 14 alcoholic drinks per week

- Clinical signs and symptoms of active knee infection or crystal disease of either knee
within 1 month of screening

- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout,
ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV,
viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis

- Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or
planned chemotherapeutic treatment.

- A gout attack in the past 2 years.

- Diseases of the spine, hip or other lower extremity joints judged by the investigator
to be contributing to the pain in either knee (i.e. sciatica, nerve pain, hip OA).
Note: Patients with hip replacement in either hip may be enrolled provided there is
sufficient pain relief after hip replacement that analgesics are not required.

- Untreated symptomatic injury of either knee (e.g., acute traumatic injury, anterior
cruciate ligament injury, clinically symptomatic meniscus injury characterized by a
mechanical issue such as locking or catching).

- Uncontrolled diabetes (HbA1c >7.2)

- Women who report pregnancy or childbearing potential and not using acceptable
contraceptive measures (oral contraceptive, long acting reversible contraceptive
therapy) (due to the potential for change in body mass and distribution to alter knee
symptoms over the period of follow-up).

- Presence of surgical hardware or other foreign body intended to treat arthritis or
cartilage-related pathology in either knee.

- Arthroscopy or open surgery of either knee within 6 months of screening.

- Planned/anticipated surgery of either knee during the study period.

- Use of systemic immunosuppressant within 6 weeks of screening.

- Oral corticosteroids (investigational or marketed) within 2 weeks of screening (unless
on chronic stable dose for >3 months).

- IA corticosteroid (investigational or marketed) in either knee within 3 months of
screening.

- IV or IM (Intramuscular) Corticosteroid injection (investigational or marketed) within
3 months of screening.

- Any other IA drug/biologic use within 6 months of screening or 5 half-lives (whichever
is longer) (e.g., hyaluronic acid, platelet-rich plasma (PRP) injection, stem cells,
prolotherapy and amniotic fluid injection).

- Any documented clinically significant degree of cognitive impairment or other
condition, finding, or psychiatric illness at screening which, in the opinion of the
investigator, could compromise subject safety.

- Any condition other than OA of the knee which, in the opinion of the investigator,
affects the ability to ambulate to a sufficient degree to interfere with the
assessment of the safety and treatment effects of the study injection.

- Participated in any interventional drug or device trial within 30 days prior to
screening or concurrent participation in another research study that could complicate
interpretation of the study findings.