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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hip implant1 | Experimental | 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. |
|
| Hip implant2 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G7 | Device | The Biomet G7â„¢ 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 G7â„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the safety and effectiveness of patients (Harris Hip Score) | Harris Hip Score | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Gruen zone analysis | Gruen zone analysis of the femoral component and Charnley-DeLee zone analysis of the acetabular system | Immediate post-op, 6 months, 1 year, 2 year |
| Loosening on its implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Joon Yoo, Ph.D | Seoul Nat'l Univ. Hospital | Principal Investigator |
| Kee-Hyung Rhyu, Ph.D | Kyung Hee Uni. Hospital at Gangdong | Principal Investigator |
| Seung-Jae Lim, Ph.D | Samsung Medical Center | Principal Investigator |
| Seung-Bum Han, Ph.D | Korea Uni. Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyunghee Univ. Hospital | Seoul | 134-727 | South Korea | |||
| Samsung Medical Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2018 | Jun 21, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| Exceed ABT | Device | 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). |
|
The presence of signs of loosening on its implant
| Immediate post-op, 6 months, 1 year, 2 year |
| Squeaking sounds | Number of patients with squeaking Sounds | 6 months, 1 year, 2 year |
| Dislocation | Dislocation at different follow-up visits | 6 months, 1 year, 2 year |
| Seoul |
| 135-710 |
| South Korea |
| Korea Univ. Hospital | Seoul | 152-703 | South Korea |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |