Status:
TERMINATED
A Prospective Multi-center Study on Total Hip Arthroplasty With E1
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Osteoarthritis
Eligibility:
FEMALE
20-75 years
Phase:
NA
Brief Summary
The primary objectives of this clinical study include: * Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1 * Compare E1 we...
Detailed Description
This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replace...
Eligibility Criteria
Inclusion
- Osteoarthritis
- Age between 20 - 75 at the time of operation
- Patients with limited co-morbidity -ASA I-III
- Patients must be able to understand instructions and be willing to return for follow up
Exclusion
- In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.
- Absolute contraindications include: infection, sepsis, and osteomyelitis.
- Relative contraindications include:
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
- osteomalacia,
- distant foci of infections which may spread to the implant site,
- rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
- vascular insufficiency, muscular atrophy, or neuromuscular disease.
- pregnancy
Key Trial Info
Start Date :
March 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2019
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01883492
Start Date
March 11 2013
End Date
March 15 2019
Last Update
February 17 2020
Active Locations (5)
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1
Fukuoka University School of Medicine
Fukuoka, Fukuoka, Japan, 814-0180
2
Kitasato University School of Medicine
Sagamihara, Kanagawa, Japan, 252-0374
3
Saiseikai Nakatsu Hospital
Osaka, Japan, 530-0012
4
Kitasato University Kitasato Institute Hospital
Tokyo, Japan, 108-8642