Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation

Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.

Study Overview

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

unstable distal radial fracture patients: (1) the initial dorsal angulation >20°, (2) with dorsal or volar comminution of the metaphysis, (3) shortening of radius >5 mm, and (4) with an associated ulnar fracture.

Description

Inclusion Criteria:

  • unstable distal radial fracture
  • fixed with external fixator

Exclusion Criteria:

  • multiple fracture
  • open fracture
  • nerve injury
  • vascular injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wrist motion range
Time Frame: 3 months, 6 months, and 1 year
extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination
3 months, 6 months, and 1 year
ulnar sided pain
Time Frame: 3 months, 6 months, and 1 year
presence of ulnar-sided wrist pain during daily activities was recorded
3 months, 6 months, and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic analysis
Time Frame: 6 weeks, 3 months, and 1 year
Standard anterior-posterior and lateral radiographs were obtained at each time point to evaluate fracture healing and the alignment of the distal part of the radius. Radial inclination, volar tilt, and radial height were measured
6 weeks, 3 months, and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yi-xin Chen, M.D., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE20116003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fracture of Distal End of Radius

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