A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP) (NCT02093364) | Clinical Trial Compass
WithdrawnNot Applicable
A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)
Stopped: No participants enrolled
0Started 2015-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Evaluation of the functional outcome
Timeframe: 12 Months
Trial details
NCT IDNCT02093364
SponsorAO Clinical Investigation and Publishing Documentation