- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087436
Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density (taperloc)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Gyeonggi-do, Korea, Republic of
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of
- Chung-Ang University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Taperloc Complete Standard
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.
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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.
|
Active Comparator: Taperloc Complete Microplasty
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Mineral Density
Time Frame: 1 year
|
evaluate bone mineral density around the implant
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic Evaluation,
Time Frame: 2 years
|
Radiographic measurements of stability and fixation
|
2 years
|
VAS Score
Time Frame: 2 years
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The measurement of pain intensity
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2 years
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Modified Harris Hip Score
Time Frame: 2 years
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2 years
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Radiographic Evaluation
Time Frame: 1 year
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Radiographic measurements of stability and fixation
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1 year
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Radiographic Evaluation
Time Frame: 6 Weeks
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Radiographic measurements of stability and fixation
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6 Weeks
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VAS Score
Time Frame: 1 year
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The measurement of pain intensity
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1 year
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VAS Score
Time Frame: 6 Weeks
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The measurement of pain intensity
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6 Weeks
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VAS Score
Time Frame: 6 Months
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The measurement of pain intensity
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6 Months
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Modified Harris Hip Score
Time Frame: 1 year
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1 year
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Modified Harris Hip Score
Time Frame: 6 Months
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6 Months
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Bone Mineral Density
Time Frame: Immediate post-op(2 - 4Weeks)
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Immediate post-op(2 - 4Weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yong-Chan Ha, PHD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- Principal Investigator: Young-Kyun Lee, PHD, Seoul National University Bundang Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT.CR.GH3.13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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