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The primary purpose of this study is to measure the postoperative changes in bone mineral density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard length Taperloc Complete Reduced Distal stem.
The Taperloc Microplasty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. The primary aim of this study is therefore to compare the postoperative changes in bone density with the Taperloc Microplasty stem, using the standard length Taperloc stem as a control.
In addition, the Taperloc stem has historically had a neck angle of 138°. There have been criticisms that this neck angle is too high for the typical Korean population. The newer Taperloc Complete system (both Microplasty and standard length) has a neck angle of 133°. A secondary aim is Occurrence ratio of thigh pain difference between Microplasty and standard stem in Korean Population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taperloc Complete Standard | Active Comparator | Group one will receive a total hip replacement with Taperloc Complete Standard. Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques. |
|
| Taperloc Complete Microplasty | Active Comparator | Group one will receive a total hip replacement with Taperloc Complete Microplasty.Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taperloc Complete Microplasty | Device | Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | evaluate bone mineral density around the implant | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Evaluation, | Radiographic measurements of stability and fixation | 2 years |
| VAS Score | The measurement of pain intensity |
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Inclusion Criteria:
Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
Exclusion Criteria:
Relative contraindications include:
2) Severe osteoporosis (Patients over 65 years old) 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 8) pregnancy 9) Fracture of the pelvis 10) Subcapital fractures
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Chan Ha, PHD | Chung-Ang University Hospital | Principal Investigator |
| Young-Kyun Lee, PHD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea | ||||
| Chung-Ang University Hospital |
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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 | Jan 12, 2017 |
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| Taperloc Complete Standard | Device | Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques. |
|
| 2 years |
| Modified Harris Hip Score |
| 2 years |
| Radiographic Evaluation | Radiographic measurements of stability and fixation | 1 year |
| Radiographic Evaluation | Radiographic measurements of stability and fixation | 6 Weeks |
| VAS Score | The measurement of pain intensity | 1 year |
| VAS Score | The measurement of pain intensity | 6 Weeks |
| VAS Score | The measurement of pain intensity | 6 Months |
| Modified Harris Hip Score |
| 1 year |
| Modified Harris Hip Score |
| 6 Months |
| Bone Mineral Density |
| Immediate post-op(2 - 4Weeks) |
| Seoul |
| South Korea |
| Jun 21, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| D007873 | Legg-Calve-Perthes Disease |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005271 | Femur Head Necrosis |
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