Swelling or Malrotation of Metacarpal Shaft Fractures in the Evaluation of Rotational Deformity

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00934869
First received: July 6, 2009
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition
Metacarpal Shaft Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Swelling or Malrotation of Metacarpal Shaft Fractures in the Evaluation of Rotational Deformity

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Study Start Date: August 2009
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Metacarpal Shaft Fractures

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men and Women with isolated metacarpal fractures

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. multiple fractures simultaneously
  2. fractures in both hands
  3. former fracture in one of the fingers, two palms,metacarpal,proximal phalanx (with exception of the thumb)
  4. open fracture, open wounds, infection
  5. pregnancy, inability performing full x-ray follow up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934869

Contacts
Contact: Shai Luria, M.D 972-2-6776342 ShaiL@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095      
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00934869     History of Changes
Other Study ID Numbers: LUR01-CTIL -HMO
Study First Received: July 6, 2009
Last Updated: March 21, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014