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
  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 Northwestern University:

Primary Outcome Measures:
  • Disability of Arm, Shoulder, and Hand (DASH) [ Time Frame: 1 clinic visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2010
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: John Berschback, Orthopedic surgeon, Northwestern University
ClinicalTrials.gov Identifier: NCT01269840     History of Changes
Other Study ID Numbers: STU00008411
Study First Received: January 3, 2011
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014