Back to resultsLong-Term Multicenter Evaluation of the E1® Tibial Bearing
Primary Purpose
Osteoarthritis of the Knee, Traumatic Arthritis of the Knee
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total knee arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring clinical outcomes, radiographic outcomes, total knee arthroplasty, survivorship
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E1 Tibial bearing
Arm Description
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.
Outcomes
Primary Outcome Measures
Survivorship, as determined by the implant remaining within the patient.
Secondary Outcome Measures
Full Information
NCT ID
NCT01374230
First Posted
June 14, 2011
Last Updated
July 26, 2018
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
1. Study Identification
Unique Protocol Identification Number
NCT01374230
Brief Title
Long-Term Multicenter Evaluation of the E1® Tibial Bearing
Official Title
Long-Term Multicenter Evaluation of the E1® Tibial Bearing
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee, Traumatic Arthritis of the Knee
Keywords
clinical outcomes, radiographic outcomes, total knee arthroplasty, survivorship
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E1 Tibial bearing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
Primary total knee arthroplasty surgery for the treatment of osteoarthritis.
Primary Outcome Measure Information:
Title
Survivorship, as determined by the implant remaining within the patient.
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Bragdon, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-Term Multicenter Evaluation of the E1® Tibial Bearing
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