NCT01752452

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

3.6 years

First QC Date

December 11, 2012

Last Update Submit

December 14, 2012

Conditions

Outcome Measures

Primary Outcomes (2)

  • wrist motion range

    extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination

    3 months, 6 months, and 1 year

  • ulnar sided pain

    presence of ulnar-sided wrist pain during daily activities was recorded

    3 months, 6 months, and 1 year

Secondary Outcomes (1)

  • radiographic analysis

    6 weeks, 3 months, and 1 year

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • unstable distal radial fracture
  • fixed with external fixator

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Study Officials

  • Yi-xin Chen, M.D.

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 19, 2012

Study Start

January 1, 2009

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations