Clinical trial NCT02087436: Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
Official title: Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Avascular Necrosis
Traumatic Arthritis
Rheumatoid Arthritis
Legg-Perthes Disease
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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:

1. Osteoarthritis
2. Avascular necrosis
3. Legg Perthes
4. Rheumatoid Arthritis
5. Diastrophic variant
6. Fused hip
7. Sequelae of Slipped capital epiphysis
8. Traumatic arthritis
9. Patients aged over 20
10. 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:

1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
2. 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

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 1 year
Secondary outcomes:
measure: Radiographic Evaluation,
timeFrame: 2 years
measure: VAS Score
timeFrame: 2 years
measure: Modified Harris Hip Score
timeFrame: 2 years
measure: Radiographic Evaluation
timeFrame: 1 year
measure: Radiographic Evaluation
timeFrame: 6 Weeks
measure: VAS Score
timeFrame: 1 year
measure: VAS Score
timeFrame: 6 Weeks
measure: VAS Score
timeFrame: 6 Months
measure: Modified Harris Hip Score
timeFrame: 1 year
measure: Modified Harris Hip Score
timeFrame: 6 Months
measure: Bone Mineral Density
timeFrame: Immediate post-op(2 - 4Weeks)
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Yong-Chan Ha, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Young-Kyun Lee, PHD
role: PRINCIPAL_INVESTIGATOR
References: