Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
This study is not yet open for participant recruitment.
Verified April 2013 by Rothman Institute Orthopaedics
Sponsor:
Rothman Institute Orthopaedics
Information provided by (Responsible Party):
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01566916
First received: February 24, 2012
Last updated: April 8, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | February 24, 2012 | ||||
| Last Updated Date | April 8, 2013 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Survivorship of Bone Preservation Tri-Lock femoral stem [ Time Frame: 2 years post-op ] Survivorship will be assessed via radiographic (x-ray) analysis and need for revision surgery (if patient had femoral stem removed for any reason within the first two years after surgery). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01566916 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
TUG (timed up and go) Score [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: No ] | ||||
| 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 | Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | This prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will be compared. Subjects will be randomized to surgical approach and followed for a period of two years. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE | Total Hip Arthroplasty | ||||
| Intervention ICMJE | Procedure: Total Hip Arthroplasty | ||||
| 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 | Not yet recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01566916 | ||||
| Other Study ID Numbers ICMJE | RIFJPAR 12-01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Rothman Institute Orthopaedics | ||||
| Study Sponsor ICMJE | Rothman Institute Orthopaedics | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Rothman Institute Orthopaedics | ||||
| Verification Date | April 2013 | ||||
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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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