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Trial record 1 of 2 for:    16635582 [PUBMED-IDS]
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Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis

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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
Enrollment 46
Recruitment Details Fifty patients fulfilled the inclusion criteria and consented to take part in this study.
Pre-assignment Details 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).
Arm/Group Title Hyaluronate Injection
Hide Arm/Group Description All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Period Title: Overall Study
Started 50 [1]
Completed 46 [2]
Not Completed 4
Reason Not Completed
Withdrawal by Subject             4
[1]
October, 2007
[2]
October, 2008
Arm/Group Title Hyaluronate Injection
Hide Arm/Group Description All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
39
  78.0%
>=65 years
11
  22.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
51.7  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
28
  56.0%
Male
22
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 50 participants
50
1.Primary Outcome
Title Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months
Hide Description The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The statistical analysis was done on completers.
Arm/Group Title Hyaluronate Injection
Hide Arm/Group Description:
All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.3  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hyaluronate Injection
Comments Previous report using 5 weekly injections, mean AOS score reduction is 2.6 with the SD of 1.8 in 75 patients. To test whether AOS reduction would be > 1 using pair t-test after 3 weekly injections, investigators need > 42 patients to give > 90% power to reject the null hypothesis-mean AOS score reduction <1 at 6 months, given that both the mean and standard deviation of AOS score reduction equal to 2. Considering possible dropout of participants, investigators decide to include 50 patients
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score
Hide Description The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment
Time Frame 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Ankle Sagittal Range of Motion
Hide Description Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.
Time Frame 6 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Four Clinical Balance Tests
Hide Description Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed “ Up-and-Go” test (TUG) ,Berg Balance Scale (BBS)
Time Frame 6 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title the Level of Global Satisfaction Based on a 7-point Categorical Scale
Hide Description The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.
Time Frame 6 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Systemic and Local Adverse Events Recording
Hide Description he occurrence of systemic and local adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded on a diary card
Time Frame 6 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Rescue Acetaminophen Consumption
Hide Description The use of all analgesic medication during the study period was recorded on a diary card by the patient.
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hyaluronate Injection
Hide Arm/Group Description All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
All-Cause Mortality
Hyaluronate Injection
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hyaluronate Injection
Affected / at Risk (%) # Events
Total   0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 8.7%
Hyaluronate Injection
Affected / at Risk (%) # Events
Total   4    
Skin and subcutaneous tissue disorders   
brief post injection pain *  3/3 (100.00%)  3
local pruritis *  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
One limitation includes the absence of a control group, thus the placebo effects associated with joint injections were not investigated.
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
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