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Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01374230
Enrollment
500
Registered
2011-06-15
Start date
2011-09-30
Completion date
2021-09-30
Last updated
2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee, Traumatic Arthritis of the Knee

Keywords

clinical outcomes, radiographic outcomes, total knee arthroplasty, survivorship

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.

Interventions

PROCEDURETotal knee arthroplasty

Primary total knee arthroplasty surgery for the treatment of osteoarthritis.

Sponsors

Stanford University
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Göteborg University
CollaboratorOTHER
Hospital Universitario La Paz
CollaboratorOTHER
Hvidovre University Hospital
CollaboratorOTHER
Seoul National University Hospital
CollaboratorOTHER
Ulsan University Hospital
CollaboratorOTHER
Sydney Private Hospital, Australia
CollaboratorUNKNOWN
Kennedy Center at Ascension Mercy Hospital
CollaboratorOTHER
Southern Joint Replacement Institute
CollaboratorUNKNOWN
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Male or Female * 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

* 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

Design outcomes

Primary

MeasureTime frame
Survivorship, as determined by the implant remaining within the patient.10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026