Trial Outcomes & Findings for Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis (NCT NCT00642382)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

At 4, 12 and 26 weeks post 3rd injection

Results posted on

2017-08-17

Participant Flow

participants were not randomized and did not receive any intervention

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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.	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.	Total Total of all reporting groups
Age, Categorical <=18 years	—	—	0 n=27 Participants
Age, Categorical Between 18 and 65 years	—	—	0 n=27 Participants
Age, Categorical >=65 years	—	—	0 n=27 Participants
Sex: Female, Male Female	—	—	0 n=27 Participants
Sex: Female, Male Male	—	—	0 n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 4, 12 and 26 weeks post 3rd injection

Outcome measures

Outcome data not reported

Adverse Events

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director Clinical Operations

Cartiva, Inc

Phone: 770-754-3805

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER