Back to resultsTaperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density (taperloc)
Primary Purpose
Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Taperloc Complete Microplasty
Taperloc Complete Standard
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang Hospital
- Chung-Ang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Taperloc Complete Standard
Taperloc Complete Microplasty
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Bone Mineral Density
evaluate bone mineral density around the implant
Secondary Outcome Measures
Radiographic Evaluation,
Radiographic measurements of stability and fixation
VAS Score
The measurement of pain intensity
Modified Harris Hip Score
Over all Survivorship
Harris Hip Score
Radiographic Evaluation
Radiographic measurements of stability and fixation
Radiographic Evaluation
Radiographic measurements of stability and fixation
VAS Score
The measurement of pain intensity
VAS Score
The measurement of pain intensity
VAS Score
The measurement of pain intensity
Modified Harris Hip Score
Over all Survivorship
Harris Hip Score
Modified Harris Hip Score
Over all Survivorship
Harris Hip Score
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02087436
Brief Title
Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
Acronym
taperloc
Official Title
Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis, Legg-Perthes Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Taperloc Complete Standard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Taperloc Complete Microplasty
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Taperloc Complete Microplasty
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Taperloc Complete Standard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone Mineral Density
Description
evaluate bone mineral density around the implant
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Radiographic Evaluation,
Description
Radiographic measurements of stability and fixation
Time Frame
2 years
Title
VAS Score
Description
The measurement of pain intensity
Time Frame
2 years
Title
Modified Harris Hip Score
Description
Over all Survivorship
Harris Hip Score
Time Frame
2 years
Title
Radiographic Evaluation
Description
Radiographic measurements of stability and fixation
Time Frame
1 year
Title
Radiographic Evaluation
Description
Radiographic measurements of stability and fixation
Time Frame
6 Weeks
Title
VAS Score
Description
The measurement of pain intensity
Time Frame
1 year
Title
VAS Score
Description
The measurement of pain intensity
Time Frame
6 Weeks
Title
VAS Score
Description
The measurement of pain intensity
Time Frame
6 Months
Title
Modified Harris Hip Score
Description
Over all Survivorship
Harris Hip Score
Time Frame
1 year
Title
Modified Harris Hip Score
Description
Over all Survivorship
Harris Hip Score
Time Frame
6 Months
Title
Bone Mineral Density
Description
Two X-ray beams with different energy levels are aimed at the patient's bones.
DEXA
evaluate the bone mineral density around the implant
Time Frame
Immediate post-op(2 - 4Weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Chan Ha, PHD
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young-Kyun Lee, PHD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
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