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

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Triamcinolone acetonide extended-release injectable suspension; Drug: Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension

• Registration Number: NCT05058209
• Lead Sponsor: ROC Foundation

Brief 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.

Detailed Description

Individuals with knee osteoarthritis (OA) often experience pain and difficulty completing many everyday activities, such as walking or climbing stairs. It is a major cause of lost work time and a serious disability for many people. Although there is no cure for arthritis, there are many treatment options available to help manage pain and keep people active.

The ZILRETTA knee injection and CELESTONE knee injection are both FDA approved, extended-release corticosteroid, and are both common nonsurgical treatment options for patients with OA. Currently, there are no studies that have compared ZILRETTA and CELESTONE SOLUSPAN.

c. Aims Specific Aim 1: To determine the difference between intra-articular (IA) injection of Zilretta and intra-articular injection of Celestone in patients with knee OA improves physical performance (OARSI recommended physical performance measures).

Primary Hypothesis 1: Patients who receive knee IA injection of Zilretta or Celestone experience improved physical performance detectable at 6 weeks and 12 weeks.

Specific Aim 2: To determine the difference between IA injection of Zilretta and IA injection of Celestone in patients with knee OA improves physical function (KOOS-PF).

Hypothesis 2: Patients who receive knee IA injection of Zilretta or Celestone report improved patient-reported physical function (KOOS-PS) at 6 weeks and 12 weeks.

Specific Aim 3: To determine the difference between knee IA injection of Zilretta or Celestone in patients with knee OA improves quality of life (KOOS-QoL).

Hypothesis 3: Patients who receive knee IA injection of Zilretta or Celestone report improved quality of life (KOOS-QoL) detectable at 6 weeks and 12 weeks.

Specific Aim 4: To determine the difference between knee IA injection of Zilretta or Celestone in patients with knee OA improves pain based on numeric pain rating scale.

Hypothesis 3: Patients who receive knee IA injection of Zilretta or Celestone report improved pain level detectable at 6 weeks and 12 weeks.

II. Research Plan and Design

1. Study Objective The goal of this study is to evaluate the efficacy of Zilretta compared to Celestone for improving quality of life, pain, neuromuscular function, and physical performance.

2. Study Design The proposed study will compare Zilretta and Celestone effectiveness on patient-reported outcomes (quality of life, neuromuscular functioning, and pain) and physical performance (30-second chair standing test, 40m fast-paced walking test, stair ascent) related to knee arthritis. Patients will be chosen based on the level of arthritis of the knee and interest in non-surgical treatment options. After informed consent but before injection, Patients will be randomized into Zilretta or Celestone treatment arms. Patients will be consented and seen at baseline, in clinic at 6-weeks, and phone call follow-up at 12-weeks. Demographic information as well as any comorbidity or adverse events related to poor healing will be recorded.

Baseline

After completing informed consent but prior to injection, patients will complete:

* OARSI recommended physical performance tests (30-second chair standing test, 40m fast-paced walking test, stair ascent)

* KOOS-PS (Physical Function Shortform) - 7 questions

* KOOS-Quality of life subscale (QoL) - 4 questions

* Numerical Rating Scale (NRS) 6-week (Post 1)

During the 6-week follow up visit with the PI, patients will complete:

* OARSI recommended physical performance tests (30-second chair standing test, 40m fast-paced walking test, stair ascent) 12 weeks after treatment

* KOOS-PS (Physical Function Shortform) - 7 questions

* KOOS-Quality of life subscale (QoL) - 4 questions

* Numerical Rating Scale (NRS) 12-week (Post 2)

At 12-weeks post-injection, the Clinical Research Coordinator (CCRC) or Research Assistant (RA) will call each patient and patients will complete:

* KOOS-PS (Physical Function Shortform) - 7 questions

* KOOS-Quality of life subscale (QoL) - 4 questions

* Numerical Rating Scale (NRS)

If patients indicate any adverse events, high levels of pain, or have medical questions, the CCRC or RA will schedule the patient to be seen by the PI.

Study Timeline

• Study Start: 2020-11-30
• Primary Completion: 2021-04-28
• Study Completion: 2021-04-28
• Status Verified: 2021-09
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Study First Posted: 2021-09-27
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Triamcinolone acetonide extended-release injectable suspension	Triamcinolone acetonide extended-release injectable suspension. Single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL). For intra-articular use only and should not be administered by the following routes: epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, subcutaneous.
Arm 2	Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension	Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension, USP 6 mg per mL, 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. When oral therapy is not feasible, the Injectable Suspension is indicated for intramuscular use only.

Primary Outcome Measures

Name	Time	Method
OARSI - 30-second chair standing test	12 week (removed due to COVID)	The maximum number of chair stand repetitions possible in a 30 second period (2-4).
OARSI - 30-second Chair Stand	6 week (removed due to COVID)	The maximum number of chair stand repetitions possible in a 30 second period (2-4).
OARSI - stair ascent	12 week (removed due to COVID)	The time (in seconds) it takes to ascend and descend a flight of stairs (2-6). The number of stairs will depend on individual environmental situations. Where possible, the 9-step stair test with 20cm (8 inch) step height and handrail is recommended.
KOOS-PS (Physical Function Shortform)	12 week	Scoring: Never/none=0, Monthly/mild=1, Weekly/moderate=2, Daily/severe=3, Always/extreme=4. Calculate the mean score for the 11 items, and divide by the maximum possible score for each item (i.e. 4). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems.; The normalized score is transformed to meet this standard. Please use the formula provided below. 100 - \[(mean score PF1-PF11)/4 \*100\]
KOOS-Quality of life subscale (QoL)	12 week	The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
OARSI - 40m Fast Paced Walk	12 week (removed due to COVID)	A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) (2).
Numerical Rating Scale (NRS)	12 week	patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable

Trial Locations

Locations (1)

Reno Orthopedic Center; 🇺🇸 Reno, Nevada, United States