OSTEOARTHRITIS
Conditions
Keywords
Osteoarthritis, Hyaluronic Acid
Brief summary
The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.
Detailed description
The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection.
Interventions
DEVICEAgilus
Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
DEVICENormal saline
Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Sponsors
Cartiva, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Chronic, unilateral ankle pain(i.e., in only one ankle) for at least 6 months * Diagnosis of ankle OA confirmed by radiographs (X-ray)and clinical exam * Are normally active, without aid of mobility devices(such as crutch, walker or cane)
Exclusion criteria
* Have used oral steroids within 30 days (inhaled or topical steroids are acceptable) * Have received intra-articular injections of hyaluronic acid in any joint in the last 9 months * Have received steroid injections in any joint in last 3 months * Have had previous surgery or arthroscopy on the affected ankle in the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain. | At 4, 12 and 26 weeks post 3rd injection |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject's Global Assessment, Quality of Life and an Individual Subject Responder Analysis. | At 4, 12 and 26 weeks post 3rd injection |
Countries
United States
Participant flow
Recruitment details
participants were not randomized and did not receive any intervention
Participants by arm
| Arm | Count |
|---|---|
| Active Agilus (Hyaluronic Acid)
Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks. | 0 |
| Control Normal Saline
Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | Total | — |
|---|---|---|
| Age, Categorical <=18 years | 0 | — |
| Age, Categorical >=65 years | 0 | — |
| Age, Categorical Between 18 and 65 years | 0 | — |
| Region of Enrollment United States | — | — participants |
| Sex: Female, Male Female | 0 | — |
| Sex: Female, Male Male | 0 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain.
Time frame: At 4, 12 and 26 weeks post 3rd injection
Population: Zero patients were analyzed for this study due to the study being closed 2 months after it started. Data were not collected
Secondary
Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject's Global Assessment, Quality of Life and an Individual Subject Responder Analysis.
Time frame: At 4, 12 and 26 weeks post 3rd injection