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OpenTrials
Completed

NCT Number: NCT01269840

Comparison of Two Radial Head Implants

In severe injuries of the radial head with multiple, displaced fracture fragments and concomitant ligament damage, excision of the fragments and replacement of the radial head with a metallic implant are indicated. Current radial head implants are composed of metal or a combination of metal and high molecular weight polyethylene. The prostheses are assembled intra-operatively as a solid unit (monopolar) or as an articulating implant with motion between the stem and head (bi-polar). The stem of the implant is inserted into the proximal radius for support and can be classified as either loose-fitting or fixed. According to the investigators, there are no studies that directly compare the clinical and radiographic outcomes between different radial head implant designs. The purpose of this retrospective study is to compare the clinical and radiographic results in patients treated for an irreparable radial head fracture with either a smooth stem, bipolar radial head implant or a monopolar, in-growth radial head implant. The study findings may provide useful clinical information regarding the similarities and differences in these two implant designs.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University/Northwestern Memorial Hospital, Chicago, Illinois, United States

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About this study

Data has been completed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suffered radial head fracture requiring radial head replacement with the Katalyst or Acumed Radial Head Implant from 2002-2009

Exclusion criteria

  • Unwilling to provide informed consent
  • Traumatic brain injury that occurred at the time of elbow fracture

Treatment and study plan

Primary outcomes

  1. Disability of Arm, Shoulder, and Hand (DASH)

    Time frame: 1 clinic visit

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • North Shore University Hospital
  • Rush University

Registry information

Official study title

Comparison of Monopolar In-Growth and Loose Bipolar Radial Head Implants in the Treatment of Irreparable Radial Head Fractures

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jan 4, 2011
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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