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Clinical Trials/NCT02093364
NCT02093364WithdrawnNot Applicable

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

AO Clinical Investigation and Publishing Documentation0 sitesStarted: July 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Primary Endpoint
Evaluation of the functional outcome
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

Outcomes

Primary Outcomes

Evaluation of the functional outcome

Time Frame: 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 Outcomes

  • Evaluation of functional outcome(24 months)
  • Range of motion(12 months)
  • Adverse events(12 months)

Investigators

Sponsor
AO Clinical Investigation and Publishing Documentation
Sponsor Class
Other
Responsible Party
Sponsor

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