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

Sponsor
AO Clinical Investigation and Publishing Documentation (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02093364
Collaborator
(none)
0
Enrollment
6
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)
    Study Start Date :
    Jul 1, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Jan 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Range of motion [12 months]

      To investigate range of motion of the injured limb as compared to the contralateral side

    3. Adverse events [12 months]

      To evaluate if the related adverse events have an effect on quality of life (EQ5D)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    • Prisoner

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AO Clinical Investigation and Publishing Documentation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AO Clinical Investigation and Publishing Documentation
    ClinicalTrials.gov Identifier:
    NCT02093364
    Other Study ID Numbers:
    • FR Radial Head Prosthesis
    First Posted:
    Mar 21, 2014
    Last Update Posted:
    Aug 12, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:
    Osteoarthritis
    Fractures, Bone
    Radius Fractures

    Study Results

    No Results Posted as of Aug 12, 2020