Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density

Conditions
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Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis, Legg-Perthes Disease

Intervention / Treatment
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* Device: Taperloc Complete Microplasty
* Device: Taperloc Complete Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suitable for primary Total Hip Replacement Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of: Osteoarthritis Avascular necrosis Legg Perthes Rheumatoid Arthritis Diastrophic variant Fused hip Sequelae of Slipped capital epiphysis Traumatic arthritis Patients aged over 20 Patients must be able to understand instructions and be willing to return for follow-up Exclusion Criteria: Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: uncooperative patient or patient with neurologic disorders who are incapable of following directions, Small Femoral canal 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Taperloc Complete Standard<br>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. | Device: Taperloc Complete Standard<br>* 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.<br>|
| Active Comparator: Taperloc Complete Microplasty<br>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. | Device: Taperloc Complete Microplasty<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density | evaluate bone mineral density around the implant | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Evaluation, | Radiographic measurements of stability and fixation | 2 years | 
| VAS Score | The measurement of pain intensity | 2 years | 
| Modified Harris Hip Score | Over all Survivorship 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 | Over all Survivorship Harris Hip Score | 1 year | 
| Modified Harris Hip Score | Over all Survivorship Harris Hip Score | 6 Months | 
| Bone Mineral Density | Two X-ray beams with different energy levels are aimed at the patient's bones. DEXA evaluate the bone mineral density around the implant | Immediate post-op(2 - 4Weeks) |