Comparison of Two Radial Head Implants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rush University
North Shore University Hospital
Information provided by (Responsible Party):
John Berschback, Northwestern University
ClinicalTrials.gov Identifier:
NCT01269840
First received: January 3, 2011
Last updated: April 9, 2013
Last verified: April 2013

January 3, 2011
April 9, 2013
March 2010
June 2012   (final data collection date for primary outcome measure)
Disability of Arm, Shoulder, and Hand (DASH) [ Time Frame: 1 clinic visit ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01269840 on ClinicalTrials.gov Archive Site
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Comparison of Two Radial Head Implants
Comparison of Monopolar In-Growth and Loose Bipolar Radial Head Implants in the Treatment of Irreparable Radial Head Fractures

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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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Patients suffering radial head fractures, with or without other elbow injuries, requiring radial head replacement

Radial Head Fractures
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01269840
STU00008411
Yes
John Berschback, Northwestern University
Northwestern University
  • Rush University
  • North Shore University Hospital
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Northwestern University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP