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
1 other identifier
observational
41
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2010
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedOctober 7, 2014
October 1, 2014
2.3 years
January 3, 2011
October 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Disability of Arm, Shoulder, and Hand (DASH)
1 clinic visit
Eligibility Criteria
Patients suffering radial head fractures, with or without other elbow injuries, requiring radial head replacement
You may qualify if:
- Suffered radial head fracture requiring radial head replacement with the Katalyst or Acumed Radial Head Implant from 2002-2009
You may not qualify if:
- Unwilling to provide informed consent
- Traumatic brain injury that occurred at the time of elbow fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Rush Universitycollaborator
- North Shore University Hospitalcollaborator
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Berschback, MD
Northwestern University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopedic surgeon
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 4, 2011
Study Start
March 1, 2010
Primary Completion
June 1, 2012
Study Completion
September 1, 2013
Last Updated
October 7, 2014
Record last verified: 2014-10