NCT00934869

Brief Summary

Rotational deformity or malunion causes the most significant functional deficit in these common fractures. The evaluation of the rotation may be performed with the metacarpophalangeal joints flexed although postoperative swelling may not enable this examination with flexion of the fingers. Furthermore, it has been shown that swelling may cause rotation of the digit itself. The investigators propose that the swelling may cause a mistake in the estimation of rotation, during surgery and early follow up period. This is of special importance when open reduction and rigid fixation is performed. Methods: Prospective analysis of XX isolated metacarpal fractures treated, in YY patients was performed. End-on view of the finger-nail was taken with a digital camera on the day of OR, at 2 weeks and at 1 year. The photos were taken on a standard apparatus and from a distance of XX cm and evaluated using ZZ software in comparison with photos taken of the other hand, according to the involved digit. Range of motion, type of fracture and type of fixation were compared.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

5.6 years

First QC Date

July 6, 2009

Last Update Submit

March 21, 2013

Conditions

Study Arms (1)

Metacarpal Shaft Fractures

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and Women with isolated metacarpal fractures

You may qualify if:

  • isolated metacarpal fractures in one hand- fingers 2, 3, 4, 5
  • treated with cast or surgical treatment , closed or open reduction

You may not qualify if:

  • multiple fractures simultaneously
  • fractures in both hands
  • former fracture in one of the fingers, two palms,metacarpal,proximal phalanx (with exception of the thumb)
  • open fracture, open wounds, infection
  • pregnancy, inability performing full x-ray follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah Medical Organization

Jerusalem, Israel

NOT YET RECRUITING

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 8, 2009

Study Start

August 1, 2009

Primary Completion

March 1, 2015

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations