Comparison of Two Radial Head Implants

Completed

• Conditions: Radial Head Fractures

• Registration Number: NCT01269840
• Lead Sponsor: Northwestern University

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.

Detailed Description

Data has been completed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2012-06
• Study Completion: 2013-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-05
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Suffered radial head fracture requiring radial head replacement with the Katalyst or Acumed Radial Head Implant from 2002-2009

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Exclusion Criteria

• Unwilling to provide informed consent
• Traumatic brain injury that occurred at the time of elbow fracture

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability of Arm, Shoulder, and Hand (DASH)	1 clinic visit

Trial Locations

Locations (3)

Rush University/Midwest Orthopaedics at Rush; 🇺🇸 Chicago, Illinois, United States

Northwestern University/Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

North Shore University Hospital; 🇺🇸 Evanston, Illinois, United States