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

Not Applicable

Completed

• Conditions: Traumatic Arthritis; Rheumatoid Arthritis; Avascular Necrosis; Legg-Perthes Disease; Osteoarthritis
• Interventions: Device: Taperloc Complete Microplasty; Device: Taperloc Complete Standard

• Registration Number: NCT02087436
• Lead Sponsor: Zimmer Biomet

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

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-14
• Primary Completion: 2014-07
• Status Verified: 2019-07
• Study Completion: 2019-12
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taperloc Complete Microplasty	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.
Taperloc Complete Standard	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.

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	1 year	evaluate bone mineral density around the implant

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of