Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
NCT ID: NCT00957970
Last Updated: 2009-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2006-07-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Stemless femoral component
Stemless PROXIMA femoral component
Stemless femoral component
Total hip femoral component anatomically designed for a proximal fit without a stem
Stemmed femoral component
IPS, proximal anatomical fit stemmed femoral component
IPS, Depuy cementless femoral stem
Anatomical proximal fitted cementless stemmed femoral component
Interventions
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Stemless femoral component
Total hip femoral component anatomically designed for a proximal fit without a stem
IPS, Depuy cementless femoral stem
Anatomical proximal fitted cementless stemmed femoral component
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* foot and ankle disorders limiting ambulation of the patient
* Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
* Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
ALL
No
Sponsors
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Ewha Womans University
OTHER
Responsible Party
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Ewha Womans University Mokdong Hospital Joint Replacement Center
Principal Investigators
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Young-Hoo Kim, MD
Role: STUDY_DIRECTOR
Korean Joint replacement Center
Locations
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Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Countries
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References
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Gulow J, Scholz R, Freiherr von Salis-Soglio G. [Short-stemmed endoprostheses in total hip arthroplasty]. Orthopade. 2007 Apr;36(4):353-9. doi: 10.1007/s00132-007-1071-x. German.
Albanese CV, Santori FS, Pavan L, Learmonth ID, Passariello R. Periprosthetic DXA after total hip arthroplasty with short vs. ultra-short custom-made femoral stems: 37 patients followed for 3 years. Acta Orthop. 2009 Jun;80(3):291-7. doi: 10.3109/17453670903074467.
Renkawitz T, Santori FS, Grifka J, Valverde C, Morlock MM, Learmonth ID. A new short uncemented, proximally fixed anatomic femoral implant with a prominent lateral flare: design rationals and study design of an international clinical trial. BMC Musculoskelet Disord. 2008 Nov 4;9:147. doi: 10.1186/1471-2474-9-147.
Kim YH. Cementless total hip arthroplasty with a close proximal fit and short tapered distal stem (third-generation) prosthesis. J Arthroplasty. 2002 Oct;17(7):841-50. doi: 10.1054/arth.2002.33555.
Other Identifiers
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2009-7-17
Identifier Type: -
Identifier Source: org_study_id
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