Evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem compared to patients who received the Exceed ABT Acetabular system with the same combination
This study will be a multi-center randomized controlled study. Eligible patients will be randomly assigned to receive a combination of G7 Acetabular system with CoC articulation and Taperloc Complete Microplasty stem or Exceed ABT Acetabular system with CoC articulation and Taperloc Complete Microplasty stem. Patient demographics, preoperative clinical outcomes, operative information, postoperative clinical outcome, radiographic assessment, incidence of squeaking, incidence of dislocation, implant survivorship and adverse events will be collected prospectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
The Biomet G7™ Acetabular System has been designed to provide more options to surgeons for treatment of patients needing total hip arthroplasty, while concurrently simplifying the surgical process with well-designed, modular components and corresponding instruments. The G7™ Acetabular System includes three liner types; ArComXL highly-crosslinked or E-1 Vitamin E-infused polyethylnene and a Biolox Delta (Ceramtec, Plochingen, Germany) ceramic liner.
The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).
Kyunghee Univ. Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea Univ. Hospital
Seoul, South Korea
the safety and effectiveness of patients (Harris Hip Score)
Harris Hip Score
Time frame: 1 year
Gruen zone analysis
Gruen zone analysis of the femoral component and Charnley-DeLee zone analysis of the acetabular system
Time frame: Immediate post-op, 6 months, 1 year, 2 year
Loosening on its implant
The presence of signs of loosening on its implant
Time frame: Immediate post-op, 6 months, 1 year, 2 year
Squeaking sounds
Number of patients with squeaking Sounds
Time frame: 6 months, 1 year, 2 year
Dislocation
Dislocation at different follow-up visits
Time frame: 6 months, 1 year, 2 year
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