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

Failed Conservative Radial Head Fracture Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02093364
• Other study ID #: FR Radial Head Prosthesis
• Status: Withdrawn
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Fractures, Bone
• Joint Diseases
• Post-traumatic Deformity or Arthroses
• Radius Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the functional outcome	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	Evaluation of functional outcome	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
Secondary	Range of motion	To investigate range of motion of the injured limb as compared to the contralateral side	12 months
Secondary	Adverse events	To evaluate if the related adverse events have an effect on quality of life (EQ5D)	12 months