Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Osteoarthritis of the Knee Clinical Trial

Official title:

Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01374230
• Other study ID #: 2010-P-001922
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2011
• Est. completion date: September 2021

Study information

• Verified date: July 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee
• Traumatic Arthritis of the Knee

Intervention

Procedure:
• Total knee arthroplasty
Primary total knee arthroplasty surgery for the treatment of osteoarthritis.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship, as determined by the implant remaining within the patient.		10 years