Subcapital and Shaft Fractures of the 5. Metacarpal

Fracture Clinical Trial

Official title:

Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01242982
• Other study ID #: TOSL-2010
• Status: Terminated
• Phase: N/A
• First received: November 16, 2010
• Last updated: April 7, 2015
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2015
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out the best treatment for subcapital and shaft fractures of the 5. metacarpal.

It is a prospective randomized multicenter study. Comparing only fractures dislocated more than 30 degrees.

One group will be operated with intramedullary pins and one group will be treated conservatively with reduction and then Plaster of Paris for 3 weeks.

All patients will be followed up after 3, 6 and 12 months.

Description:

See above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• voluntarily, only isolated subcapital og shaft fracture of the 5. metacarpal,operated/reduction within 10 days of injury,not intoxicated,degree of fracture dislocation minimum 30 degrees measured on the X-ray.

Exclusion Criteria:

• open fractures, fractures of the head of 5. metacarpal/intraarticular fractures, patients who wants to be followed up at Hospitals outside the study area, earlier injury of the hand that might have influence on function.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

Procedure:
• Closed reduction and fixation with 2 pins
Closed reduction and fixation with 2 antegrade intramedullary Kirschner wires. Cast for 2 weeks. Control after 2 and 5 weeks. Thereafter a control after 3,6 and 12 months
• Reduction and Plaster of Paris
Closed reduction in local anesthesia and a Plaster of Paris for max. 3 weeks. Control after 1 and 3 weeks, thereafter control after 3,6 and 12 months

Locations

Country	Name	City	State
Norway	Ålesund sjukehus, Helse Sunmøre	Ålesund	Møre og Romsdal
Norway	Kristiansund sykehus, Helse Nord Møre og Romsdal	Kristiansund-N	Møre og Romsdal
Norway	Molde sykehus, Helse Nordmøre og Romsdal	Molde	Møre og Romsdal
Norway	Sykehuset Namsos, Helse Nord-Trøndelag	Namsos	Nord -Trøndelag
Norway	Sykehuset i Vestfold-Tønsberg	Tønsberg

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal	The goal is 200 patients with shaft and subcapital fractures of the 5.metacarpal. In each group the goal is 100 patients there 50 patients will be operated (2 intramedullary pins) and 50 patients undergo conservative treatment. The follow up is 1 year.	2 -3 years	Yes