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NCT01269840 · ClinicalTrials.gov registry record

Comparison of Two Radial Head Implants

A clinical trial of Radial Head Fractures, sponsored by Northwestern University.

Completed
Registry status
41
Enrollment target
3
Study locations

NCT01269840: Completed study of Radial Head Fractures, sponsored by Northwestern University.

NCT01269840 is a study of Radial Head Fractures that has completed, run by Northwestern University. The registered enrollment target is 41 participants. The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01269840, a study of Radial Head Fractures, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
41 participants
Enrollment target
3
Study locations

Study 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.

Conditions Studied

Study Locations (3)

Illinois

  • Northwestern University/Northwestern Memorial Hospital - Chicago
  • Rush University/Midwest Orthopaedics at Rush - Chicago
  • North Shore University Hospital - Evanston

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2010-03
Est. Completion 2013-09
Northwestern University

1,209 total trials

What the finished NCT01269840 record still lists

NCT01269840 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 41 participants, a relatively small participant target.

The record links to 1 condition, with Radial Head Fractures appearing as the primary indexed condition, and to 0 interventions.

NCT01269840 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT01269840 about?

NCT01269840 is a clinical study titled "Comparison of Two Radial Head Implants". 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...

What is the current status of trial NCT01269840?

This trial is currently completed. The enrollment target is 41 participants. The study started on 2010-03. Estimated completion is 2013-09.

What conditions does trial NCT01269840 study?

This clinical trial studies the following conditions: Radial Head Fractures.

Who is sponsoring clinical trial NCT01269840?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01269840 being conducted?

This trial has 3 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01269840, the US trial registry maintained by the National Library of Medicine. NCT01269840 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.