Degenerative ArthritisNCT00588783
I-beam and Cruciate Tibial Components Used in Total Knee Replacement
An observational study of Degenerative Arthritis and Osteoarthritis, run by Biomet Orthopedics, LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Arthritis, Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- I-beam design and Cruciate design
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Oct 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients requiring total knee replacement.
Who may be able to join
- Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment are involved.
- Patients requiring correction of varus, valgus, or posttraumatic deformity
- Patients requiring correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Who cannot join
- Patients with infection, sepsis, or osteomyelitis.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement.
- Being tested
- I-beam design, Cruciate design
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-beam designDevice
This group will utilize tibial components with an I-beam design for total knee replacement.
Cruciate designDevice
This group will utilize tibial components with cruciate designs for total knee replacement.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Device: I-beam design | |
| 2 | Not described Receives: Device: Cruciate design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision rate
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 posted9 Jan 2008 (estimated)
- Study startAug 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Lexington Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588783
- Sponsor's protocol ID
- 104-U-013
- Status last verified
- Jun 2017
- First submitted
- 21 Dec 2007
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-beam and Cruciate Tibial Components Used in Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00588783
- Acronym / sponsor ID
- 104-U-013
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- New Lexington Clinic
- Study start
- Aug 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Jan 2008 (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.
The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: I-beam design |
| 2 | – | Device: Cruciate design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients requiring total knee replacement.
Key inclusion criteria (3 listed)
- Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment are involved.
- Patients requiring correction of varus, valgus, or posttraumatic deformity
- Patients requiring correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Key exclusion criteria (1 listed)
- Patients with infection, sepsis, or osteomyelitis.
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 |
|---|---|---|
| I-beam designThis group will utilize tibial components with an I-beam design for total knee replacement. | Device | 1 |
| Cruciate designThis group will utilize tibial components with cruciate designs for total knee replacement. | Device | 2 |
Primary outcome
Revision rate
Time frame: 10 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Arthritis and Osteoarthritis, run by Biomet Orthopedics, LLC 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Jun 2017. 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?
The study was stopped early. 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?
Revision rate (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 21 Jun 2017.