Long-Term Multicenter Evaluation of the E1® Tibial Bearing
1 other identifier
interventional
500
1 country
1
Brief Summary
This study has been designed to document the long-term outcome of the E1® Tibial Bearings used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic analysis and patient reported outcomes will be used as follow-up measures to track wear, mechanical performance, and patient satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJuly 30, 2018
July 1, 2018
10 years
June 14, 2011
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survivorship, as determined by the implant remaining within the patient.
10 years
Study Arms (1)
E1 Tibial bearing
EXPERIMENTALAll 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.
Interventions
Primary total knee arthroplasty surgery for the treatment of osteoarthritis.
Eligibility Criteria
You may qualify if:
- Male or Female
- 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
You may not qualify if:
- Subjects with osteoporosis, osteomalacia, or neuromuscular disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Stanford Universitycollaborator
- Aalborg University Hospitalcollaborator
- Göteborg Universitycollaborator
- Hospital Universitario La Pazcollaborator
- Hvidovre University Hospitalcollaborator
- Seoul National University Hospitalcollaborator
- Ulsan University Hospitalcollaborator
- Sydney Private Hospital, Australiacollaborator
- Kennedy Center at Ascension Mercy Hospitalcollaborator
- Southern Joint Replacement Institutecollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Bragdon, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director, Clinical Studies
Study Record Dates
First Submitted
June 14, 2011
First Posted
June 15, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
July 30, 2018
Record last verified: 2018-07