Comparison of Two Radial Head Implants
Completed
Conditions studied: Radial Head Fractures
In brief
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.
Key facts
- Study ID
- NCT01269840
- Run by
- Northwestern University
- People needed
- 41
- Starts
- 2010-03-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2014-10-07
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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