ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    16635582 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis

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.
ClinicalTrials.gov Identifier: NCT00918736
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : June 11, 2009
Last Update Posted : June 17, 2009
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Kaohsiung Veterans General Hospital.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis
Intervention: Drug: sodium hyaluronate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Fifty patients fulfilled the inclusion criteria and consented to take part in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient withdrew his consent and one had a fear of injection prior to receiving the first injection. Two patients withdrew from the study before the third injection (one because of an unrelated intercurrent illness and one moving to another city).

Reporting Groups
  Description
Hyaluronate Injection All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.

Participant Flow:   Overall Study
    Hyaluronate Injection
STARTED   50 [1] 
COMPLETED   46 [2] 
NOT COMPLETED   4 
Withdrawal by Subject                4 
[1] October, 2007
[2] October, 2008



  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.
No text entered.

Reporting Groups
  Description
Hyaluronate Injection All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.

Baseline Measures
   Hyaluronate Injection 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   39 
>=65 years   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.7  (14.4) 
Gender 
[Units: Participants]
 
Female   28 
Male   22 
Region of Enrollment 
[Units: Participants]
 
Taiwan   50 


  Outcome Measures

1.  Primary:   Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months   [ Time Frame: baseline and 6 months ]

2.  Secondary:   The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   10/2009  

3.  Secondary:   Ankle Sagittal Range of Motion   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2009  

4.  Secondary:   Four Clinical Balance Tests   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2009  

5.  Secondary:   the Level of Global Satisfaction Based on a 7-point Categorical Scale   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   10/2009  

6.  Secondary:   Systemic and Local Adverse Events Recording   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   10/2009  

7.  Secondary:   Rescue Acetaminophen Consumption   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   10/2009  


  Serious Adverse Events


  Other Adverse Events


  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
One limitation includes the absence of a control group, thus the placebo effects associated with joint injections were not investigated.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Shu-Fen Sun
Organization: Veterans General Hospital, Kaohsiung, Taiwan
phone: 886-73422121 ext 4210
e-mail: sfsun.tw@yahoo.com.tw


Publications:

Responsible Party: Shu-Fen Sun, Kaohsiung Veteran General Hospital
ClinicalTrials.gov Identifier: NCT00918736     History of Changes
Other Study ID Numbers: NSC96-2314-B-075B-006
First Submitted: March 16, 2009
First Posted: June 11, 2009
Results First Submitted: March 16, 2009
Results First Posted: June 11, 2009
Last Update Posted: June 17, 2009