Osteoarthritis of the KneeNCT01374230
Long-Term Multicenter Evaluation of the E1® Tibial Bearing
A study testing Total knee arthroplasty in people with Osteoarthritis of the Knee and Traumatic Arthritis of the Knee, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee, Traumatic Arthritis of the Knee
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Being tested
- Total knee arthroplasty
- Keywords
- clinical outcomes, radiographic outcomes, total knee arthroplasty, survivorship
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Primary total knee arthroplasty surgery for the treatment of osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| E1 Tibial bearing | Experimental | 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. Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship, as determined by the implant remaining within the patient.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Charles R. Bragdon, Massachusetts General Hospital
- Investigators
- Charles Bragdon, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374230
- Sponsor's protocol ID
- 2010-P-001922
- Status last verified
- Jul 2018
- First submitted
- 14 Jun 2011
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Multicenter Evaluation of the E1® Tibial Bearing
- ClinicalTrials.gov ID
- NCT01374230
- Acronym / sponsor ID
- 2010-P-001922
- Keywords
- clinical outcomes, radiographic outcomes, total knee arthroplasty, survivorship
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- 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
- Study start
- Sep 2011
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E1 Tibial bearing | Experimental | Procedure: Total knee arthroplastyAll 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyPrimary total knee arthroplasty surgery for the treatment of osteoarthritis. | Procedure or surgery | E1 Tibial bearing |
Primary outcome
Survivorship, as determined by the implant remaining within the patient.
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Bragdon, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Osteoarthritis of the Knee and Traumatic Arthritis of the Knee, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship, as determined by the implant remaining within the patient. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.