Subcapital and Shaft Fractures of the 5. Metacarpal

NCT01242982 | Terminated DMC

• 1 other identifier: TOSL-2010
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

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.

Conditions

Fracture

Keywords

5. metacarpal fracture/fractures; subcapital; shaft; closed

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Operation

EXPERIMENTAL

Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires.

Procedure: Closed reduction and fixation with 2 pins

Conservative treatment

ACTIVE COMPARATOR

Treated conservatively with reduction and then Plaster of Paris.

Procedure: Reduction and Plaster of Paris

Interventions

Closed reduction and fixation with 2 pins PROCEDURE

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

Operation

Reduction and Plaster of Paris PROCEDURE

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

Conservative treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (5)

Ålesund sjukehus, Helse Sunmøre

Ålesund, Møre og Romsdal, 6026, Norway

Location

Kristiansund sykehus, Helse Nord Møre og Romsdal

Kristiansund-N, Møre og Romsdal, 6508, Norway

Location

Molde sykehus, Helse Nordmøre og Romsdal

Molde, Møre og Romsdal, 6412, Norway

Location

Sykehuset Namsos, Helse Nord-Trøndelag

Namsos, Nord -Trøndelag, 7801, Norway

Location

Sykehuset i Vestfold-Tønsberg

Tønsberg, 3103, Norway

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Calcium Sulfate

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Minerals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ivar Rossvoll, dr. med.

  St. Olavs Hospital, orthopedic department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

NO (5)