Degenerative Conditions of the Radial Head/NeckNCT00533234
ExploR® Modular Radial Head Data Collection
An observational study of Degenerative Conditions of the Radial Head/Neck and Post-traumatic Conditions of the Radial Head/Neck, run by Biomet Orthopedics, LLC 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. This data collection effort will document the clinical outcomes of the radial head. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Conditions of the Radial Head/Neck, Post-traumatic Conditions of the Radial Head/Neck
- What is being tested?
- ExploR® Modular Radial Head
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be implanted with the ExploR® Modular Radial Head.
Who may be able to join
- The inclusion criteria will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device.
- 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
Show all 10Show fewer
- Revision following failed radial head arthroplasty
- The device is intended for single use with or without bone cement.
- Modular Radial Head replacement prostheses have received FDA clearance for cemented and non-cemented application.
- Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity.
Who cannot join
- The exclusion criteria will be the same as the contraindications stated in the FDA cleared labeling (510(k) K040611) and (510(k) K051385) for the device. These contraindications include:
- Absolute contraindications:
- Infection
- Sepsis
- Osteomyelitis
- Relative contraindications:
Show all 12Show fewer
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
- Osteoporosis
- Metabolic disorders which may impair bone function
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Trial locations and contacts
1 site in 1 country.
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. This data collection effort will document the clinical outcomes of the radial head.
Read the detailed description
Data collection intervals are:
Pre-operative, Operative, 3 Months Post-op, 1 Year Post-op, 3 Years Post-op, and 5 Years Post-op.
Data collected includes:
Historical data, Operative record, Mayo Clinic Performance Index for the Elbow, Quick DASH Outcome Measure, Complications, Lost to Follow-up, Protocol Deviations, and Radiographic evaluation of elbow and wrist.
- Conditions
- Degenerative Conditions of the Radial Head/Neck, Post-traumatic Conditions of the Radial Head/Neck
- Being tested
- ExploR® Modular Radial Head
- Keywords
- Elbow fracture, Elbow dislocation, Radial head fracture, Radial neck fracture
- Medical subject headings
- Elbow Fractures, Radial Head and Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExploR® Modular Radial HeadDevice
The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation
Measured: 5 years
Secondary outcomes (1)
Revisions, Complications, Adverse Events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startDec 2009
- Study completionJun 2010
Why it stopped: There was a lack of business need to continue this data collection.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Conditions of the Radial Head/NeckStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Beres, MD, Principal investigator, Biomet Orthopedics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533234
- Sponsor's protocol ID
- 116-U-001
- Status last verified
- Jun 2017
- First submitted
- 20 Sep 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
- ExploR® Modular Radial Head Data Collection
- ClinicalTrials.gov ID
- NCT00533234
- Acronym / sponsor ID
- 116-U-001
- Conditions
- Degenerative Conditions of the Radial Head/Neck, Post-traumatic Conditions of the Radial Head/Neck
- Keywords
- Elbow fracture, Elbow dislocation, Radial head fracture, Radial neck fracture
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: There was a lack of business need to continue this data collection.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Sep 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. This data collection effort will document the clinical outcomes of the radial head.
Detailed description
Data collection intervals are:
Pre-operative, Operative, 3 Months Post-op, 1 Year Post-op, 3 Years Post-op, and 5 Years Post-op.
Data collected includes:
Historical data, Operative record, Mayo Clinic Performance Index for the Elbow, Quick DASH Outcome Measure, Complications, Lost to Follow-up, Protocol Deviations, and Radiographic evaluation of elbow and wrist.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be implanted with the ExploR® Modular Radial Head.
Key inclusion criteria (10 listed)
- The inclusion criteria will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device.
- 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:
- Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty
Key exclusion criteria (12 listed)
- The exclusion criteria will be the same as the contraindications stated in the FDA cleared labeling (510(k) K040611) and (510(k) K051385) for the device. These contraindications include:
- Infection
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
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 |
|---|---|---|
| ExploR® Modular Radial HeadThe ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement. | Device | – |
Primary outcome
Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation
Time frame: 5 years
1 secondary outcome
Revisions, Complications, Adverse Events
Time frame: 5 years
Results and safety
The study was stopped early (reason given: There was a lack of business need to continue this data collection.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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.
Ken Beres, MD principal investigator
Biomet Orthopedics, LLC
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 Conditions of the Radial Head/Neck and Post-traumatic Conditions of the Radial Head/Neck, 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 10 inclusion and 12 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 (reason given: There was a lack of business need to continue this data collection.). 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?
Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation (time frame: 5 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.