G7 Acetabular System vs. Exceed ABT Acetabular System in THA
- Conditions
- Rheumatoid ArthritisOsteoarthritis Arthritis
- Interventions
- Device: Exceed ABTDevice: G7
- Registration Number
- NCT02340390
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed total hip arthroplasty.
- age over 20 years old
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
- osteomalacia,
- distant foci of infections which may spread to the implant site,
- rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
- vascular insufficiency, muscular atrophy, or neuromuscular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hip implant2 Exceed ABT 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). Hip implant1 G7 The Biomet G7 Acetabular System is a modular acetabular system, offering two types of acetabular shells. The shells are available in either a solid shell design, with an apical plug, or a limited hole with an apical plug and optional screw holes. Components are available in numerous designs and sizes intended for both primary and/or revision applications.
- Primary Outcome Measures
Name Time Method the safety and effectiveness of patients (Harris Hip Score) 1 year Harris Hip Score
- Secondary Outcome Measures
Name Time Method Gruen zone analysis Immediate post-op, 6 months, 1 year, 2 year Gruen zone analysis of the femoral component and Charnley-DeLee zone analysis of the acetabular system
Loosening on its implant Immediate post-op, 6 months, 1 year, 2 year The presence of signs of loosening on its implant
Dislocation 6 months, 1 year, 2 year Dislocation at different follow-up visits
Squeaking sounds 6 months, 1 year, 2 year Number of patients with squeaking Sounds
Trial Locations
- Locations (3)
Kyunghee Univ. Hospital
đŸ‡°đŸ‡·Seoul, Korea, Republic of
Korea Univ. Hospital
đŸ‡°đŸ‡·Seoul, Korea, Republic of
Samsung Medical Center
đŸ‡°đŸ‡·Seoul, Korea, Republic of