A Trial Comparing Mini-posterior Approach and Direct Anterior Approach
This study is currently recruiting participants.
Verified January 2012 by OrthoCarolina Research Institute, Inc.
Sponsor:
OrthoCarolina Research Institute, Inc.
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01024309
First received: November 30, 2009
Last updated: October 10, 2012
Last verified: January 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 30, 2009 | ||||||||
| Last Updated Date | October 10, 2012 | ||||||||
| Start Date ICMJE | November 2009 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. [ Time Frame: 3 wk, 6 wk, 12 mo ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01024309 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Trial Comparing Mini-posterior Approach and Direct Anterior Approach | ||||||||
| Official Title ICMJE | A Prospective, Randomized, Clinical Trial Comparing the Clinical Outcomes Following Total Hip Arthroplasty by a Single Surgeon Using Either a Mini-posterior Approach or a Direct Anterior Approach | ||||||||
| Brief Summary | The purpose is to determine if differences exist in the attainment of functional milestones that reflect activities of daily living between mini-posterior and direct anterior approach total hip arthroplasty (THA). The investigators also hope to determine if the general health outcome after direct anterior total hip arthroplasty was better than that after mini-posterior-incision total hip arthroplasty as measured with Short Form-12 (SF-12) scores, and to evaluate variation of surgical factors of the two procedures on the basis of the operative time, component positioning, and occurrence of early complications. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 112 | ||||||||
| Estimated Completion Date | June 2014 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 25 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01024309 | ||||||||
| Other Study ID Numbers ICMJE | 09072 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | OrthoCarolina Research Institute, Inc. | ||||||||
| Study Sponsor ICMJE | OrthoCarolina Research Institute, Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | OrthoCarolina Research Institute, Inc. | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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