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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yi-xin Chen, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT01752452
First received: December 11, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition
Fracture of Distal End of Radius
Fracture of Ulnar Styloid

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • wrist motion range [ Time Frame: 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
    extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination

  • ulnar sided pain [ Time Frame: 3 months, 6 months, and 1 year ] [ Designated as safety issue: No ]
    presence of ulnar-sided wrist pain during daily activities was recorded


Secondary Outcome Measures:
  • radiographic analysis [ Time Frame: 6 weeks, 3 months, and 1 year ] [ Designated as safety issue: No ]
    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


Enrollment: 106
Study Start Date: January 2009
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 11, 2012
Last Updated: December 14, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013