Total Elbow ArthroplastyNCT00974298
Uncemented Total Elbow Arthroplasty Data Collection
An observational study of Total Elbow Arthroplasty, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to document the performance and clinical outcomes of uncemented total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand Center. The press-fit use technique is often used because of complications with cement loosening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Elbow Arthroplasty
- What is being tested?
- Total elbow replacement arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2013
- 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: Patients who require total elbow arthroplasty.
Who may be able to join
- Any patient who has had a total elbow arthroplasty using a press-fit technique at the Vanderbilt Hand \& Upper Extremity Center
Who cannot join
- Patients less than 18 years old
- For chart review and post-operative enrollment the patients must have adequate radiographs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Hand & Upper Extremity Center
Nashville, Tennessee, 37232-8828
About this study
The purpose of this study is to document the performance and clinical outcomes of uncemented total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand Center. The press-fit use technique is often used because of complications with cement loosening.
Read the detailed description
The three parts of this study will be:
Retrospective Chart Review-
A chart review will be completed on all patients that have had an uncemented total elbow arthroplasty using the press-fit technique at Vanderbilt Hand \& Upper Extremity Center. The chart review will include:
- A historical data form
- An operative data form
- A radiographic assessment form
Questionnaire Mailing- We will mail prospective study patients a DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire to complete with a mailing letter explaining the request for this information. The DASH will be modified to ask patients regarding their pre-operative time as well.
Clinical Data Collection-
We will enroll patients who have already had/or will be having a uncemented total elbow arthroplasty using the press-fit technique. If the patient already has a file completed through the chart review we will not complete the historical data form, operative form, or previous radiograph assessments. If the patient does not have a file completed through the chart review the data collection will include:
- An Informed Consent Document
- A historical data form
- An operative data form
- A radiographic assessment form
- Patient-completed DASH questionnaire
- Elbow Assessment Form
- Conditions
- Total Elbow Arthroplasty
- Being tested
- Total elbow replacement arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total elbow replacement arthroplastyProcedure or surgery
Total elbow arthroplasty using pressfit technique in which no cement is used.
| Study group | Role | What they receive |
|---|---|---|
| Elbow replacement | There are no other arms other then an uncemented total elbow replacement. Receives: Procedure: Total elbow replacement arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty
Measured: Pre-operative to five year post-operative appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Elbow ArthroplastyStudies 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
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Lee, Vanderbilt University
- Investigators
- Donald Lee, M.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974298
- Sponsor's protocol ID
- 090342
- Status last verified
- Aug 2014
- First submitted
- 2 Sep 2009
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncemented Total Elbow Arthroplasty Data Collection
- ClinicalTrials.gov ID
- NCT00974298
- Acronym / sponsor ID
- 090342
- Conditions
- Total Elbow Arthroplasty
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Sep 2009 (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 document the performance and clinical outcomes of uncemented total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand Center. The press-fit use technique is often used because of complications with cement loosening.
Detailed description
The three parts of this study will be:
Retrospective Chart Review-
A chart review will be completed on all patients that have had an uncemented total elbow arthroplasty using the press-fit technique at Vanderbilt Hand \& Upper Extremity Center. The chart review will include:
- A historical data form
- An operative data form
- A radiographic assessment form
Questionnaire Mailing- We will mail prospective study patients a DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire to complete with a mailing letter explaining the request for this information. The DASH will be modified to ask patients regarding their pre-operative time as well.
Clinical Data Collection-
We will enroll patients who have already had/or will be having a uncemented total elbow arthroplasty using the press-fit technique. If the patient already has a file completed through the chart review we will not complete the historical data form, operative form, or previous radiograph assessments. If the patient does not have a file completed through the chart review the data collection will include:
- An Informed Consent Document
- A historical data form
- An operative data form
- A radiographic assessment form
- Patient-completed DASH questionnaire
- Elbow Assessment Form
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elbow replacement | – | Procedure: Total elbow replacement arthroplastyThere are no other arms other then an uncemented total elbow replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require total elbow arthroplasty.
Key inclusion criteria (1 listed)
- Any patient who has had a total elbow arthroplasty using a press-fit technique at the Vanderbilt Hand \& Upper Extremity Center
Key exclusion criteria (2 listed)
- Patients less than 18 years old
- For chart review and post-operative enrollment the patients must have adequate radiographs.
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 elbow replacement arthroplastyTotal elbow arthroplasty using pressfit technique in which no cement is used. | Procedure or surgery | Elbow replacement |
Primary outcome
Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty
Time frame: Pre-operative to five year post-operative appointment
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 6 Aug 2014.
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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.
Donald Lee, M.D. principal investigator
Vanderbilt University
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 Total Elbow Arthroplasty, run by Vanderbilt University 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 1 inclusion and 2 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 6 Aug 2014. 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?
Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty (time frame: Pre-operative to five year post-operative appointment). 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 6 Aug 2014.