Walking Aids in the Management of Hip Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meika A. Fang, MD, Arthritis Foundation
ClinicalTrials.gov Identifier:
NCT00506714
First received: July 20, 2007
Last updated: September 28, 2012
Last verified: September 2012
Results First Received: February 6, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis
Intervention: Device: single point cane

  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
Group 1 Healthy adults
Group 2 Adults with symptomatic hip osteoarthritis

Participant Flow:   Overall Study
    Group 1     Group 2  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  



  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
Group 1 Healthy adults
Group 2 Adults with symptomatic hip osteoarthritis
Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     5     11  
>=65 years     7     8     15  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 4.4     67  ± 5.9     66  ± 5.2  
Gender  
[units: participants]
     
Female     2     2     4  
Male     11     11     22  
Region of Enrollment  
[units: participants]
     
United States     13     13     26  



  Outcome Measures
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1.  Primary:   Gait Velocity   [ Time Frame: Baseline ]

2.  Secondary:   Gait Velocity With a Cane in Hip OA Subjects   [ Time Frame: Baseline ]

3.  Secondary:   Gait Velocity   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
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Results Point of Contact:  
Name/Title: Meika A. Fang, MD
Organization: Arthritis Foundation
phone: 310-478-3711 ext 84503
e-mail: meika.fang@va.gov


No publications provided


Responsible Party: Meika A. Fang, MD, Arthritis Foundation
ClinicalTrials.gov Identifier: NCT00506714     History of Changes
Other Study ID Numbers: 2007-030430
Study First Received: July 20, 2007
Results First Received: February 6, 2012
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board