Fracture of the Radial Head Which is Not Amendable to an Adequate OsteosynthesisNCT02093364
A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)
An observational study of Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis and Post-traumatic Deformity or Arthroses, run by AO Clinical Investigation and Publishing Documentation.
Trial summary
The purpose of this focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis, Post-traumatic Deformity or Arthroses, Failed Open Reduction Internal Fixation (ORIF) of a Radial Head Fracture
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jan 2016
- How long will I take part?
- 12 Months
- 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: Primary care centers
Who may be able to join
- Age 18 years or older
- Use of a short-or long-stemmed DePuy Synthes Radial Head Prosthesis due to any of the following indications:
- Fresh fracture of the radial head which is not amendable to an adequate -steosynthesis
- Post-traumatic deformity or arthroses
- Failed open reduction internal fixation (ORIF)
- Failed conservative radial head fracture treatment
Show all 10Show fewer
- Informed consent obtained, i.e.:
- Ability to understand the content of the patient information / Informed Consent Form
- Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- Signed and dated Ethics Committee (EC) / Institutional Review Board (IRB) approved written informed consent
Who cannot join
- Active infection at the affected elbow
- Any not medically managed severe systemic disease
- Pregnancy
- Prisoner
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
About this study
The purpose of this focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the functional outcome
Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 1 year in patients treated with a RHP
Measured: 12 Months
Secondary outcomes (3)
Evaluation of functional outcome
Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 2 years
Measured: 24 months
Range of motion
To investigate range of motion of the injured limb as compared to the contralateral side
Measured: 12 months
Adverse events
To evaluate if the related adverse events have an effect on quality of life (EQ5D)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionJan 2016
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of the Radial Head Which is Not Amendable to an Adequate OsteosynthesisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093364
- Sponsor's protocol ID
- FR Radial Head Prosthesis
- Status last verified
- Aug 2020
- First submitted
- 18 Mar 2014
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)
- ClinicalTrials.gov ID
- NCT02093364
- Acronym / sponsor ID
- FR Radial Head Prosthesis
- Conditions
- Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis, Post-traumatic Deformity or Arthroses, Failed Open Reduction Internal Fixation (ORIF) of a Radial Head Fracture, Failed Conservative Radial Head Fracture Treatment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Mar 2014 (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 focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care centers
Key inclusion criteria (10 listed)
- Age 18 years or older
- Use of a short-or long-stemmed DePuy Synthes Radial Head Prosthesis due to any of the following indications:
- Informed consent obtained, i.e.:
Key exclusion criteria (5 listed)
- Active infection at the affected elbow
- Any not medically managed severe systemic disease
- Pregnancy
- Prisoner
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the functional outcome
Time frame: 12 Months
Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 1 year in patients treated with a RHP
3 secondary outcomes
Evaluation of functional outcome
Time frame: 24 months
Range of motion
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis and Post-traumatic Deformity or Arthroses, run by AO Clinical Investigation and Publishing Documentation.
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 5 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: withdrawn, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Evaluation of the functional outcome (time frame: 12 Months). 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 12 Aug 2020.