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

Withdrawn

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

• Registration Number: NCT02093364
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-21
• Study Start: 2015-07
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the functional outcome	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of functional outcome	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
Range of motion	12 months	To investigate range of motion of the injured limb as compared to the contralateral side
Adverse events	12 months	To evaluate if the related adverse events have an effect on quality of life (EQ5D)