Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-10-31

Brief Summary

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A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.

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Detailed Description

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Conditions

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Fractures of the Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operative treatment

Closed reduction of the fracture and osteosynthesis with 2-3 intramedullary K-wires (Bouquet method), cast treatment for 7-10 days followed by 5 weeks of buddy-strapping before removal of the K-pins

Group Type ACTIVE_COMPARATOR

Bouquet pinning of the 5th metacarpal bone

Intervention Type PROCEDURE

The fracture is reduced under general anesthesia and 2-3 K-pins are introduced in the medullar cavity to keep the fracture in the reduced position

Conservative treatment

No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bouquet pinning of the 5th metacarpal bone

The fracture is reduced under general anesthesia and 2-3 K-pins are introduced in the medullar cavity to keep the fracture in the reduced position

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone

Exclusion Criteria

* Less than 30 degrees of volar angulation in the fracture
* rotational deformity
* pseudoclawing
* intra-articular involvement
* ad latus displacement more than one half of a bone width
* concomitant fractures or soft tissue damage
* admittance more than 14 days after injury
* non-compliant patient (language, drugs, tourist)
* patient who refuses to participate in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No