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Status unknownNCT01374230Updated Jul 30, 2018

Long-Term Multicenter Evaluation of the E1® Tibial Bearing

An interventional study of Total knee arthroplasty in Osteoarthritis of the Knee and Traumatic Arthritis of the Knee, sponsored by Massachusetts General Hospital. Status unknown at 1 site in United States. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-30.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis of the Knee
  • Traumatic Arthritis of the Knee

Keywords

  • clinical outcomes
  • radiographic outcomes
  • total knee arthroplasty
  • survivorship
03

In context

Osteoarthritis, Knee

3,303 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 500 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,537 studies on the registry; 447 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    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.

    Procedure: Total knee arthroplasty

Interventions

  • ProcedureTotal knee arthroplasty

    Primary total knee arthroplasty surgery for the treatment of osteoarthritis.

06

What researchers measure

Primary outcomes

  1. Survivorship, as determined by the implant remaining within the patient.

    Time frame: 10 years

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01374230
Lead sponsor
Massachusetts General Hospital
Collaborators
Stanford University, Aalborg University Hospital, Göteborg University, Hospital Universitario La Paz, Hvidovre University Hospital, Seoul National University Hospital, Ulsan University Hospital, Sydney Private Hospital, Australia, Kennedy Center at Ascension Mercy Hospital, Southern Joint Replacement Institute
Responsible party
Charles R. Bragdon (Associate Director, Clinical Studies, Massachusetts General Hospital) — Principal investigator
First posted
Jun 15, 2011
Start date
Sep 2011
Primary completion
Sep 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Jul 30, 2018

Study contacts

Charles Bragdon, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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