Elbow FractureNCT00521846
ExploR™ Modular Radial Head Data Collection
An observational study of Elbow Fracture, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Fracture
- What is being tested?
- Biomet Explor Modular Radial Head Replacement
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to 16 Jan 2026
- 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: Study population will be any individual that seeks care at Vanderbilt University Medical Center for a radial head fracture/dislocation that requires replacement using a Biomet Explor Modular Radial Head implant (routine care).
Who may be able to join
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- Joint destruction and/or subluxation visible on x-ray
- Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty
- Patient selection factors to be considered:
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions, including control of weight and activity levels
Show all 9Show fewer
- A good nutritional state of the patient
- The patient must have reached full skeletal maturity
- Exclusion Criteria Patients who have infection, sepsis, and osteomyelitis Patients who are uncooperative or have neurologic disorders who is capable or unwilling to follow directions Patients with distant foci of infections which may spread to the implant site Patients with rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Patients who are pregnant Patients who are under 18 years of age Patients who have had fractures of the humerus Patients who have had revisions where other devices and treatments have failed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University
Nashville, Tennessee, 37232-8828
About this study
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.
Read the detailed description
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.
The radial head on which data will be collected is legally marketed and is not investigational or experimental. This data collection effort will document the clinical outcomes of the radial head.
Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational surgical techniques used. The devices and products are to be used in accordance with their instructions for use and/or approved labeling.
The outcomes and data collected include:
The Mayo Clinic Performance Index for The Elbow The Quick DASH Outcome Measure Radiographic Evaluation
All revisions, complications, and adverse events will also be recorded. Inclusion Criteria
Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- Joint destruction and/or subluxation visible on x-ray
- Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty
Patient selection factors to be considered:
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions, including control of weight and activity levels
- A good nutritional state of the patient
- The patient must have reached full skeletal maturity
Exclusion Criteria Patients who have infection, sepsis, and osteomyelitis Patients who are uncooperative or have neurologic disorders who is capable or unwilling to follow directions Patients with distant foci of infections which may spread to the implant site Patients with rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Patients who are pregnant Patients who are under 18 years of age Patients who have had fractures of the humerus Patients who have had revisions where other devices and treatments have failed
- Conditions
- Elbow Fracture
- Being tested
- Biomet Explor Modular Radial Head Replacement
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomet Explor Modular Radial Head ReplacementDevice
As part of the patient's routine care, they will undergo a radial head replacement using the Biomet Explor Modular Radial Head system.
| Study group | Role | What they receive |
|---|---|---|
| 1 | As part of their routine care, patient's will receive Biomet modular radial head replacement. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes. Receives: Device: Biomet Explor Modular Radial Head Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will measure the performance and clinical outcomes of the ExploR Modular Radial Head based on data collection from the following forms: The Mayo Clinic Performance Index for The Elbow, The Quick DASH Outcome Measure, Radiographic Evaluation
Measured: 5 years
Patient examination measurements and radiographic measurements will be used to determine the effects of the Modular Radial Head implant.
Measured: Pre-op, 6 week, 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startAug 2007
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Weikert, Vanderbilt University Medical Center
- Investigators
- Donald H Lee, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521846
- Sponsor's protocol ID
- 070155
- Status last verified
- May 2026
- First submitted
- 27 Aug 2007
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExploR™ Modular Radial Head Data Collection
- ClinicalTrials.gov ID
- NCT00521846
- Acronym / sponsor ID
- 070155
- Conditions
- Elbow Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 28 Aug 2007 (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 prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.
Detailed description
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.
The radial head on which data will be collected is legally marketed and is not investigational or experimental. This data collection effort will document the clinical outcomes of the radial head.
Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational surgical techniques used. The devices and products are to be used in accordance with their instructions for use and/or approved labeling.
The outcomes and data collected include:
The Mayo Clinic Performance Index for The Elbow The Quick DASH Outcome Measure Radiographic Evaluation
All revisions, complications, and adverse events will also be recorded. Inclusion Criteria
Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- Joint destruction and/or subluxation visible on x-ray
- Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty
Patient selection factors to be considered:
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions, including control of weight and activity levels
- A good nutritional state of the patient
- The patient must have reached full skeletal maturity
Exclusion Criteria Patients who have infection, sepsis, and osteomyelitis Patients who are uncooperative or have neurologic disorders who is capable or unwilling to follow directions Patients with distant foci of infections which may spread to the implant site Patients with rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Patients who are pregnant Patients who are under 18 years of age Patients who have had fractures of the humerus Patients who have had revisions where other devices and treatments have failed
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Biomet Explor Modular Radial Head ReplacementAs part of their routine care, patient's will receive Biomet modular radial head replacement. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be any individual that seeks care at Vanderbilt University Medical Center for a radial head fracture/dislocation that requires replacement using a Biomet Explor Modular Radial Head implant (routine care).
Key inclusion criteria (9 listed)
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- Joint destruction and/or subluxation visible on x-ray
- Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions, including control of weight and activity levels
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biomet Explor Modular Radial Head ReplacementAs part of the patient's routine care, they will undergo a radial head replacement using the Biomet Explor Modular Radial Head system. | Device | 1 |
Primary outcome
We will measure the performance and clinical outcomes of the ExploR Modular Radial Head based on data collection from the following forms: The Mayo Clinic Performance Index for The Elbow, The Quick DASH Outcome Measure, Radiographic Evaluation
Time frame: 5 years
Patient examination measurements and radiographic measurements will be used to determine the effects of the Modular Radial Head implant.
Time frame: Pre-op, 6 week, 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. Will not be shared.
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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 H Lee, MD principal investigator
Vanderbilt University Medical Center
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 Elbow Fracture, run by Vanderbilt University Medical Center 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 9 inclusion and 0 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: finished, as of the sponsor's last update on 26 May 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
We will measure the performance and clinical outcomes of the ExploR Modular Radial Head based on data collection from the following forms: The Mayo Clinic Performance Index for The Elbow, The Quick DASH Outcome Measure, Radiographic Evaluation (time frame: 5 years). The study lists 2 primary outcomes in all. 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 26 May 2026.