Comparison of Two Radial Head Implants
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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 |
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients suffering radial head fractures, with or without other elbow injuries, requiring radial head replacement
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| 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 | |
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 May 23, 2013