Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
United States Naval Medical Center, Portsmouth
Information provided by (Responsible Party):
American Orthopaedic Society for Sports Medicine
ClinicalTrials.gov Identifier:
NCT01557868
First received: March 12, 2012
Last updated: February 19, 2014
Last verified: February 2014
Results First Received: January 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Condition: Osteoarthritis, Knee
Interventions: Device: hylan G-F 20
Device: 1% sodium hyaluronate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Synvisc (Hylan G-F 20) hylan G-F 20: Three 2 cc injections at weekly intervals
Euflexxa (1% Sodium Hyaluronate) 1% sodium hyaluronate: Three 2 cc injections at weekly intervals

Participant Flow:   Overall Study
    Synvisc (Hylan G-F 20)     Euflexxa (1% Sodium Hyaluronate)  
STARTED     103     95  
COMPLETED     76     65  
NOT COMPLETED     27     30  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Synvisc (Hylan G-F 20) hylan G-F 20: Three 2 cc injections at weekly intervals
Euflexxa (1% Sodium Hyaluronate) 1% sodium hyaluronate: Three 2 cc injections at weekly intervals
Total Total of all reporting groups

Baseline Measures
    Synvisc (Hylan G-F 20)     Euflexxa (1% Sodium Hyaluronate)     Total  
Number of Participants  
[units: participants]
  103     95     198  
Age  
[units: years]
Mean ± Standard Deviation
  46.5  ± 9.6     43.3  ± 10.4     45.0  ± 10.1  
Gender  
[units: participants]
     
Female     43     35     78  
Male     60     60     120  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     1     5     6  
Black/African American     33     21     54  
Hispanic     5     6     11  
White     62     62     124  
Other     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     103     95     198  



  Outcome Measures
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1.  Primary:   Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale   [ Time Frame: Baseline and at 6 month follow-up ]

2.  Secondary:   Visual Analogue Scale (VAS) at 6 Months   [ Time Frame: Assessments were at baseline to 6 month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Barton Mann
Organization: American Orthopaedic Society for Sports Medicine
phone: 847-292-4900
e-mail: bart@aossm.org


No publications provided


Responsible Party: American Orthopaedic Society for Sports Medicine
ClinicalTrials.gov Identifier: NCT01557868     History of Changes
Other Study ID Numbers: AOSSM 51H
Study First Received: March 12, 2012
Results First Received: January 7, 2014
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board