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

Study Overview
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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.

Official Title
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Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial

Conditions
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Fractures of the Neck

Intervention / Treatment
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* Procedure: Bouquet pinning of the 5th metacarpal bone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative treatment<br>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 | Procedure: Bouquet pinning of the 5th metacarpal bone<br>* 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<br>|
| No Intervention: Conservative treatment<br>No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick-DASH | Validated hand function score | 6 weeks, 3 months, 1 year, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | VAS scale | 6 weeks, 3 months, 1 year, 2 years | 
| Pain | VAS scale | 1 week, 6 weeks, 3 months, 1 year, 2 years | 
| Eq-5d | Validated quality of life score | 6 weeks, 3 months, 1 year, 2 years | 
| Complications | All complications are noted | 1 week, 6 weeks, 3 months, 1 year, 2 years | 
| Sick-leave | Days of sick-leave off work | 1 week, 6 weeks, 3 months (1 year, 2 years) | 
| Range of motion in the joints in the 5th finger measured by hand therapist | total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint | 3 months, 1 year, 2 years | 
| Grip strength | Compared to the non-injured hand | 3 months, 1 year, 2 years | 
| Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand |  | 6 weeks, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture, 5th metacarpal bone, Bouquet pinning, Fractures of the neck of the 5th metacarpal bone