A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)
August 11, 2020 updated by: AO Clinical Investigation and Publishing Documentation
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 Overview
Status
Withdrawn
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary care centers
Description
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of functional outcome
Time Frame: 24 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 2 years
|
24 months
|
|
Range of motion
Time Frame: 12 months
|
To investigate range of motion of the injured limb as compared to the contralateral side
|
12 months
|
|
Adverse events
Time Frame: 12 months
|
To evaluate if the related adverse events have an effect on quality of life (EQ5D)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ACTUAL)
January 1, 2016
Study Registration Dates
First Submitted
March 18, 2014
First Submitted That Met QC Criteria
March 19, 2014
First Posted (ESTIMATE)
March 21, 2014
Study Record Updates
Last Update Posted (ACTUAL)
August 12, 2020
Last Update Submitted That Met QC Criteria
August 11, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FR Radial Head Prosthesis
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis
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