Subcapital and Shaft Fractures of the 5. Metacarpal

Not Applicable

Terminated

• Conditions: Fracture
• Interventions: Procedure: Reduction and Plaster of Paris; Procedure: Closed reduction and fixation with 2 pins

• Registration Number: NCT01242982
• Lead Sponsor: St. Olavs Hospital

Brief 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.

Detailed Description

See above

Study Timeline

• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Study Start: 2011-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Reduction and Plaster of Paris	Treated conservatively with reduction and then Plaster of Paris.
Operation	Closed reduction and fixation with 2 pins	Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires.

Primary Outcome Measures

Name	Time	Method
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal	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.

Trial Locations

Locations (5)

Sykehuset Namsos, Helse Nord-Trøndelag; 🇳🇴 Namsos, Nord -Trøndelag, Norway

Sykehuset i Vestfold-Tønsberg; 🇳🇴 Tønsberg, Norway

Molde sykehus, Helse Nordmøre og Romsdal; 🇳🇴 Molde, Møre og Romsdal, Norway

Ålesund sjukehus, Helse Sunmøre; 🇳🇴 Ålesund, Møre og Romsdal, Norway

Kristiansund sykehus, Helse Nord Møre og Romsdal; 🇳🇴 Kristiansund-N, Møre og Romsdal, Norway