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

Fracture of Distal End of Radius Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752452
• Other study ID #: BE20116003
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: December 14, 2012
• Start date: January 2009
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• unstable distal radial fracture

• fixed with external fixator

Exclusion Criteria:

• multiple fracture

• open fracture

• nerve injury

• vascular injury

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fracture of Distal End of Radius
• Fracture of Ulnar Styloid
• Fractures, Bone
• Ulna Fractures

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wrist motion range	extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination	3 months, 6 months, and 1 year	No
Primary	ulnar sided pain	presence of ulnar-sided wrist pain during daily activities was recorded	3 months, 6 months, and 1 year	No
Secondary	radiographic analysis	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	No