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A Trial Comparing Mini-posterior Approach and Direct Anterior Approach

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01024309
First received: November 30, 2009
Last updated: October 28, 2014
Last verified: October 2014
Results First Received: December 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Procedure: Mini-Posterior surgical approach for total hip arthroplasty
Procedure: Direct Anterior surgical approach for total hip arthroplasty

  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
66 volunteer participants were enrolled during routine clinical practice of the principal investigator between the dates of 12/8/2009 and 10/9/2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 patients withdrew participation prior to randomization

Reporting Groups
  Description
Mini-Posterior Approach Mini-Posterior surgical approach for total hip arthroplasty
Direct Anterior Approach Direct Anterior surgical approach for total hip arthroplasty

Participant Flow:   Overall Study
    Mini-Posterior Approach     Direct Anterior Approach  
STARTED     35     31  
COMPLETED     27     27  
NOT COMPLETED     8     4  
Physician Decision                 4                 0  
Withdrawal by Subject                 4                 4  



  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.
No text entered.

Reporting Groups
  Description
Mini-Posterior Approach Mini-Posterior surgical approach for total hip arthroplasty
Direct Anterior Approach Direct Anterior surgical approach for total hip arthroplasty
Total Total of all reporting groups

Baseline Measures
    Mini-Posterior Approach     Direct Anterior Approach     Total  
Number of Participants  
[units: participants]
  35     31     66  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     17     35  
>=65 years     17     14     31  
Age  
[units: years]
Mean ± Standard Deviation
  64.2  ± 9.4     63.4  ± 8.6     63.8  ± 9.0  
Gender  
[units: participants]
     
Female     18     16     34  
Male     17     15     32  
Region of Enrollment  
[units: participants]
     
United States     35     31     66  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Days for Discontinue Assistive Devices   [ Time Frame: 6 week ]

2.  Secondary:   Harris Hip Score   [ Time Frame: 3 week ]

3.  Secondary:   Western Ontario and McMaster Universities Arthritis Index (WOMAC)   [ Time Frame: 3 week ]

4.  Secondary:   Abduction Angle   [ Time Frame: 6 wk ]

5.  Secondary:   Anteversion Angle   [ Time Frame: 6 week ]

6.  Secondary:   Harris Hip Score   [ Time Frame: 6 week ]

7.  Secondary:   WOMAC   [ Time Frame: 6 week ]

8.  Secondary:   Harris Hip Score   [ Time Frame: 12 month ]

9.  Secondary:   WOMAC   [ Time Frame: 12 month ]


  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. Susan Odum
Organization: OrthoCarolina Research Institute
phone: 704.323.2265
e-mail: Susan.Odum@OrthoCarolina.com


No publications provided


Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01024309     History of Changes
Other Study ID Numbers: 09072
Study First Received: November 30, 2009
Results First Received: December 31, 2013
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board