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Comparison of Two Radial Head Implants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269840
First Posted: January 4, 2011
Last Update Posted: October 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rush University
North Shore University Hospital
Information provided by (Responsible Party):
John Berschback, Northwestern University
  Purpose
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.

Condition
Radial Head Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Monopolar In-Growth and Loose Bipolar Radial Head Implants in the Treatment of Irreparable Radial Head Fractures

Resource links provided by NLM:


Further study details as provided by John Berschback, Northwestern University:

Primary Outcome Measures:
  • Disability of Arm, Shoulder, and Hand (DASH) [ Time Frame: 1 clinic visit ]

Enrollment: 41
Study Start Date: March 2010
Study Completion Date: September 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Detailed Description:
Data has been completed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering radial head fractures, with or without other elbow injuries, requiring radial head replacement
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269840


Locations
United States, Illinois
Northwestern University/Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University/Midwest Orthopaedics at Rush
Chicago, Illinois, United States
North Shore University Hospital
Evanston, Illinois, United States
Sponsors and Collaborators
Northwestern University
Rush University
North Shore University Hospital
Investigators
Study Director: John Berschback, MD Northwestern University
  More Information

Responsible Party: John Berschback, Orthopedic surgeon, Northwestern University
ClinicalTrials.gov Identifier: NCT01269840     History of Changes
Other Study ID Numbers: STU00008411
First Submitted: January 3, 2011
First Posted: January 4, 2011
Last Update Posted: October 7, 2014
Last Verified: October 2014

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