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

This study has been terminated.
(For safety concerns)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642382
First Posted: March 25, 2008
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cartiva, Inc.
Results First Submitted: January 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: OSTEOARTHRITIS
Interventions: Device: Agilus
Device: Normal saline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
participants were not randomized and did not receive any intervention

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Active   Control
STARTED   0   0 
COMPLETED   0   0 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Zero patients were analyzed for this study due to the study being closed 2 months after it started. Baseline data were not collected

Reporting Groups
  Description
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

Baseline Measures
   Active   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 
Age       
<=18 years         0 
Between 18 and 65 years         0 
>=65 years         0 
Sex: Female, Male       
Female         0 
Male         0 


  Outcome Measures

1.  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 ]

2.  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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director Clinical Operations
Organization: Cartiva, Inc
phone: 770-754-3805
e-mail: rtownsend@cartiva.net



Responsible Party: Cartiva, Inc.
ClinicalTrials.gov Identifier: NCT00642382     History of Changes
Other Study ID Numbers: CMI-CP-Ankle-001
First Submitted: March 19, 2008
First Posted: March 25, 2008
Results First Submitted: January 30, 2017
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017