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

Rheumatoid Arthritis Clinical Trial

— taperloc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087436
• Other study ID #: INT.CR.GH3.13
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Legg-Perthes Disease
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Device:
• 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 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	evaluate bone mineral density around the implant	1 year
Secondary	Radiographic Evaluation,	Radiographic measurements of stability and fixation	2 years
Secondary	VAS Score	The measurement of pain intensity	2 years
Secondary	Modified Harris Hip Score	Over all Survivorship; Harris Hip Score	2 years
Secondary	Radiographic Evaluation	Radiographic measurements of stability and fixation	1 year
Secondary	Radiographic Evaluation	Radiographic measurements of stability and fixation	6 Weeks
Secondary	VAS Score	The measurement of pain intensity	1 year
Secondary	VAS Score	The measurement of pain intensity	6 Weeks
Secondary	VAS Score	The measurement of pain intensity	6 Months
Secondary	Modified Harris Hip Score	Over all Survivorship; Harris Hip Score	1 year
Secondary	Modified Harris Hip Score	Over all Survivorship; Harris Hip Score	6 Months
Secondary	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)