The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Baptist Health Louisville
Louisville, Kentucky, United States
RECRUITINGSts. Mary & Elizabeth Hospital - KentuckyOne Health
Louisville, Kentucky, United States
RECRUITINGRadiographic Success as a Measure of Radiolucency and Component Migration
A subject will be considered a failure for Overall Radiographic Success if one or more of the below conditions are met: The subject will be considered a RADIOGRAPHIC FAILURE if: 1. there is a complete radiolucent line\> 3mm wide at the bone/cement interface or 2. there is a \>5 degree migration (shift) of the component or 3. there is a \>5 mm migration (shift) of the component.
Time frame: 2 years
Improvement of Harris Hip Score (with Charnley Score and other comorbidities considered)
Time frame: 2 years
Patient satisfaction clinical assessment utilizing questionnaire
Clinical assessment of patient satisfaction will be made by utilizing a Patient Satisfaction (PS) questionnaire.
Time frame: 2 years
Revision of Implant Prosthesis as a Measure of Efficacy
Time frame: 5 years
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