Subcapital and Shaft Fractures of the 5. Metacarpal
|ClinicalTrials.gov Identifier: NCT01242982|
Recruitment Status : Terminated (problems to include patients, patients not showing up at check-up)
First Posted : November 17, 2010
Last Update Posted : April 8, 2015
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.
|Condition or disease||Intervention/treatment|
|Fracture||Procedure: Closed reduction and fixation with 2 pins Procedure: Reduction and Plaster of Paris|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation|
|Study Start Date :||January 2011|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires.
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
Active Comparator: Conservative treatment
Treated conservatively with reduction and then Plaster of Paris.
Procedure: 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
- Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal [ Time Frame: 2 -3 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242982
|Kristiansund sykehus, Helse Nord Møre og Romsdal|
|Kristiansund-N, Møre og Romsdal, Norway, 6508|
|Molde sykehus, Helse Nordmøre og Romsdal|
|Molde, Møre og Romsdal, Norway, 6412|
|Ålesund sjukehus, Helse Sunmøre|
|Ålesund, Møre og Romsdal, Norway, 6026|
|Sykehuset Namsos, Helse Nord-Trøndelag|
|Namsos, Nord -Trøndelag, Norway, 7801|
|Sykehuset i Vestfold-Tønsberg|
|Tønsberg, Norway, 3103|
|Study Director:||Ivar Rossvoll, dr. med.||St. Olavs Hospital, orthopedic department|