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

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ClinicalTrials.gov Identifier: NCT01752452
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.

Condition or disease
Fracture of Distal End of Radius Fracture of Ulnar Styloid

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 106 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Study Start Date : January 2009
Primary Completion Date : August 2012
Study Completion Date : October 2012

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U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. wrist motion range [ Time Frame: 3 months, 6 months, and 1 year ]
    extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination

  2. ulnar sided pain [ Time Frame: 3 months, 6 months, and 1 year ]
    presence of ulnar-sided wrist pain during daily activities was recorded


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • unstable distal radial fracture
  • fixed with external fixator

Exclusion Criteria:

  • multiple fracture
  • open fracture
  • nerve injury
  • vascular injury
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752452


Locations
China, Jiangsu
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
Principal Investigator: Yi-xin Chen, M.D. Nanjing Drum Tower Hospital
More Information

Responsible Party: Yi-xin Chen, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT01752452     History of Changes
Other Study ID Numbers: BE20116003
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Fractures, Bone
Ulna Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries