Study Stopped
Enrollment of the subject could not reach statistically required number.
A Prospective Multi-center Study on Total Hip Arthroplasty With E1
A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
1 other identifier
interventional
153
1 country
5
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 wear used with CoCr and Biolox Delta heads
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2013
CompletedStudy Start
First participant enrolled
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedResults Posted
Study results publicly available
February 17, 2020
CompletedFebruary 17, 2020
February 1, 2020
5.9 years
January 31, 2013
January 20, 2020
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.
Immediate postoperative and 2 year postoperatively
Secondary Outcomes (12)
Harris Hip Score at 6 Month Follow-up Visit
6 month postoperative
Harris Hip Score at 1 Year Follow-up Visit
1 year postoperative
Harris Hip Score at 2 Year Follow-up Visit
2 year postoperative
Harris Hip Score at 3 Year Follow-up Visit
3 year postoperative
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
6 month postoperative
- +7 more secondary outcomes
Study Arms (2)
BIOLOX delta head
EXPERIMENTALUncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s). Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup. Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
CoCr head
ACTIVE COMPARATORUncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s). Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup. CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Interventions
JMDN classification/Class III device
JMDN classification: Class III device
JMDN classification: Class III device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (5)
Fukuoka University School of Medicine
Fukuoka, Fukuoka, 814-0180, Japan
Kitasato University School of Medicine
Sagamihara, Kanagawa, 252-0374, Japan
Saiseikai Nakatsu Hospital
Osaka, 530-0012, Japan
Kitasato University Kitasato Institute Hospital
Tokyo, 108-8642, Japan
Keio University School of Medicine
Tokyo, 160-8582, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Manager of Clinical Affairs
- Organization
- Zimmer Biomet G.K.
Study Officials
- PRINCIPAL INVESTIGATOR
Hirotsugu Ohashi, M.D., Ph.D.
Saiseikai Nakatsu Hospital
- PRINCIPAL INVESTIGATOR
Arihiko Kanaji, M.D., Ph.D.
Keio University
- PRINCIPAL INVESTIGATOR
Katsufumi Uchiyama, M.D., Ph.D.
Kitasato University School of Medicine
- PRINCIPAL INVESTIGATOR
Hironori Kaneko, M.D., Ph.D.
Kitasato University Kitasato Institute Hospital
- PRINCIPAL INVESTIGATOR
Koichi Kinoshita, M.D., Ph.D.
Fukuoka University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2013
First Posted
June 21, 2013
Study Start
March 11, 2013
Primary Completion
February 6, 2019
Study Completion
March 15, 2019
Last Updated
February 17, 2020
Results First Posted
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share