A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)

AO Clinical Investigation and Publishing Documentation

Status: Withdrawn

Conditions: Post-traumatic Deformity or Arthroses; Failed Conservative Radial Head Fracture Treatment; Failed Open Reduction Internal Fixation (ORIF) of a Radial Head Fracture; Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis

Study type: Observational

Funder types: Other

Identifiers

NCT02093364

FR Radial Head Prosthesis

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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