Trial Outcomes & Findings for The Effect of Intra-articular Bilateral Knee Injections of Zilretta on Performance Measures in Adults With Knee OA (NCT NCT03895840)

Last Updated: 2022-05-05

Results Overview

The 30 second Chair Standing Test is one of three Osteoarthritis Research Society International (OARSI) recommended minimal core set of performance-based outcome measures in OA research and clinical practice.In this test, the subject will stand up completely from the sitting position so hips and knees are fully extended, then completely back in the seated position. This will be repeated for 30 seconds and the total number of chair stands will be recorded (up and down equals one stand).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Intra-articular Zilretta Injection 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
Overall Study STARTED	70
Overall Study 6-Week Follow-Up	70
Overall Study 12-Week Follow-Up	65
Overall Study 24-Week Follow-Up	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Intra-articular Zilretta Injection 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
Overall Study Withdrawal by Subject	21

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intra-articular Zilretta Injection n=70 Participants 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
Age, Continuous	64.0 years STANDARD_DEVIATION 11.7 • n=70 Participants
Sex: Female, Male Female	43 Participants n=70 Participants
Sex: Female, Male Male	27 Participants n=70 Participants
Region of Enrollment United States	70 participants n=70 Participants
BMI	31.8 kg/m^2 STANDARD_DEVIATION 5.7 • n=70 Participants
Chair Stand (#)	7.7 stands STANDARD_DEVIATION 3.6 • n=70 Participants
Stair Climb (sec)	22.1 seconds STANDARD_DEVIATION 28.9 • n=70 Participants
40m Walk Time (sec)	37.3 seconds STANDARD_DEVIATION 26.0 • n=70 Participants
Physical Function (KOOS)	50.9 score on a scale STANDARD_DEVIATION 11.3 • n=70 Participants
Quality of Life (KOOS)	27.4 score on a scale STANDARD_DEVIATION 16.8 • n=70 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Intra-articular Zilretta Injection n=65 Participants 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
30 Second Chair Standing Test	9.5 stands Standard Error 0.5

PRIMARY outcome

Timeframe: 12 weeks

The 40-meter fast paced walk test is one of the three Osteoarthritis Research Society International recommended minimal core set of performance-based outcome measures in OA research and clinical practice.The subjects will be timed to complete a 40 m track course.

Outcome measures

Outcome measures
Measure	Intra-articular Zilretta Injection n=65 Participants 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
40m Fast Paced Walking Test (40m FPWT)	35.9 seconds Standard Error 2.6

PRIMARY outcome

Timeframe: 12 weeks

The stair climb test is one of the three Osteoarthritis Research Society International recommended minimal core set of performance-based outcome measures in OA research and clinical practice. The subject will be timed while ascending and descending 9 steps of stairs.

Outcome measures

Outcome measures
Measure	Intra-articular Zilretta Injection n=65 Participants 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
Timed Stair Climb	15.0 seconds Standard Error 1.4

SECONDARY outcome

Timeframe: 12 weeks

KOOS-Physical Function (KOOS-PS) Short Form is a parsimonious measure of physical function derived from the KOOS, which is a self-reported outcome score. The KOOS-Physical Function Short Form ranges from 0 to 100 where higher values represents a worse outcome.

Outcome measures

Outcome measures
Measure	Intra-articular Zilretta Injection n=65 Participants 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
KOOS-PS (Knee Osteoarthritis Outcome Score - Physical Function Short Form)	70.0 score on a scale Standard Error 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

KOOS-QoL a self-reported measure consisting of 4 questions assessing quality of life, which is part of the five patient-relevant subscales of KOOS.The sub scale ranges from 0 to 100 where higher values represents a better outcome

Outcome measures

Outcome measures
Measure	Intra-articular Zilretta Injection n=65 Participants 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
KOOS-QoL (Knee Osteoarthritis Outcome Score - Quality of Life)	51.9 score on a scale Standard Error 3.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

The Numeric Rating Scale for Pain (NRS for Pain) is a measure of pain intensity. The subject will rate their knee pain bilaterally on a scale from no pain (0) to worst pain imaginable (10).

Outcome measures

Outcome measures
Measure	Intra-articular Zilretta Injection n=65 Participants 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
NRS for Pain	3.3 units on a scale Standard Error 0.3

Adverse Events

Intra-articular Zilretta Injection

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intra-articular Zilretta Injection n=70 participants at risk 32 mg Zilretta in a 5ml diluent for each knee, per manufacturer guidelines Zilretta: Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
Immune system disorders Allergic rhinitis	1.4% 1/70 • Number of events 1 • 24 Weeks
Musculoskeletal and connective tissue disorders arthralgia	10.0% 7/70 • Number of events 7 • 24 Weeks
Skin and subcutaneous tissue disorders Blister	1.4% 1/70 • Number of events 1 • 24 Weeks
Blood and lymphatic system disorders Bruising	4.3% 3/70 • Number of events 3 • 24 Weeks
Blood and lymphatic system disorders Epistaxis	1.4% 1/70 • Number of events 1 • 24 Weeks
General disorders Fall	11.4% 8/70 • Number of events 8 • 24 Weeks
General disorders Flu-like symptoms	1.4% 1/70 • Number of events 1 • 24 Weeks
General disorders headache	2.9% 2/70 • Number of events 2 • 24 Weeks
Blood and lymphatic system disorders Hematuria	1.4% 1/70 • Number of events 1 • 24 Weeks
Endocrine disorders Hyperglycemia	1.4% 1/70 • Number of events 1 • 24 Weeks
Ear and labyrinth disorders Otitis media	1.4% 1/70 • Number of events 1 • 24 Weeks
Respiratory, thoracic and mediastinal disorders Rhinorrea	1.4% 1/70 • Number of events 1 • 24 Weeks
Blood and lymphatic system disorders Swelling	2.9% 2/70 • Number of events 2 • 24 Weeks
Renal and urinary disorders URI	5.7% 4/70 • Number of events 4 • 24 Weeks

Additional Information

Neil Segal, MD

University of Kansas Medical Center

Phone: 9135740961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place