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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT02093364
First received: March 18, 2014
Last updated: April 24, 2015
Last verified: March 2014
  Purpose

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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Evaluation of the functional outcome [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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:
  • Evaluation of functional outcome [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To investigate range of motion of the injured limb as compared to the contralateral side

  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate if the related adverse events have an effect on quality of life (EQ5D)


Estimated Enrollment: 60
Study Start Date: July 2015
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care centers

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT02093364     History of Changes
Other Study ID Numbers: FR Radial Head Prosthesis
Study First Received: March 18, 2014
Last Updated: April 24, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Arm Injuries
Forearm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 02, 2015