A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)
NCT ID: NCT02093364
Last Updated: 2020-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
OBSERVATIONAL
2015-07-31
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Two Radial Head Implants
NCT01269840
Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate
NCT03259906
Non Randomized Humerusshaft Fracture
NCT00205972
Restoration of the Radial Length in Compound Wrist Fractures Using Anterior Locking Plates
NCT00330122
Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating
NCT03635060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Any not medically managed severe systemic disease
* Pregnancy
* Prisoner
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FR Radial Head Prosthesis
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.