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Subcapital and Shaft Fractures of the 5. Metacarpal

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01242982
Enrollment
39
Registered
2010-11-17
Start date
2011-01-31
Completion date
2012-05-31
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture

Keywords

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

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

Interventions

PROCEDUREClosed 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

PROCEDUREReduction 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

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal2 -3 yearsThe 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026