Comparison of Two Radial Head Implants

Radial Head Fractures Clinical Trial

Official title:

Comparison of Monopolar In-Growth and Loose Bipolar Radial Head Implants in the Treatment of Irreparable Radial Head Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269840
• Other study ID #: STU00008411
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: October 5, 2014
• Start date: March 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Data has been completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Radial Head Fractures
• Radius Fractures

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	North Shore University Hospital, Rush University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability of Arm, Shoulder, and Hand (DASH)		1 clinic visit	No