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Comparison of Two Radial Head Implants

NCT ID: NCT01269840

Last Updated: 2014-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Data has been completed.

Conditions

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Radial Head Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University

OTHER

Sponsor Role collaborator

North Shore University Hospital

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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John Berschback

Orthopedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Berschback, MD

Role: STUDY_DIRECTOR

Northwestern University

Locations

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Northwestern University/Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Rush University/Midwest Orthopaedics at Rush

Chicago, Illinois, United States

Site Status

North Shore University Hospital

Evanston, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00008411

Identifier Type: -

Identifier Source: org_study_id

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