Long-Term Multicenter Evaluation of the E1® Tibial Bearing
NCT ID: NCT01374230
Last Updated: 2018-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2011-09-30
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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E1 Tibial bearing
All patients undergoing primary total knee replacement surgery will receive a tibial bearing made of E1 polyethylene, which is the material being monitored in this study.
Total knee arthroplasty
Primary total knee arthroplasty surgery for the treatment of osteoarthritis.
Interventions
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Total knee arthroplasty
Primary total knee arthroplasty surgery for the treatment of osteoarthritis.
Eligibility Criteria
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Inclusion Criteria
* 20 to 75 years of age
* Subjects requiring total knee replacement
* Subjects with the diagnosis of osteoarthritis, or traumatic arthritis
* Subjects who demonstrate the ability to return to Massachusetts General Hospital for follow-up for the next 10 years
Exclusion Criteria
* Incomplete or insufficient soft tissue around the knee
* Subjects with a limited life span
* Subjects who have difficulty comprehending the study protocol for any reason
* Subjects with disorders which may impair bone formation
* Subjects whose bony structure deviates substantially from the general norm
* Female subjects that are, or may become, pregnant while participating in this study
20 Years
75 Years
ALL
No
Sponsors
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Stanford University
OTHER
Aalborg University Hospital
OTHER
Göteborg University
OTHER
Hospital Universitario La Paz
OTHER
Hvidovre University Hospital
OTHER
Seoul National University Hospital
OTHER
Ulsan University Hospital
OTHER
Sydney Private Hospital, Australia
UNKNOWN
Kennedy Center at Ascension Mercy Hospital
OTHER
Southern Joint Replacement Institute
UNKNOWN
Massachusetts General Hospital
OTHER
Responsible Party
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Charles R. Bragdon
Associate Director, Clinical Studies
Principal Investigators
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Charles Bragdon, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2010-P-001922
Identifier Type: -
Identifier Source: org_study_id
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