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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01139528
Acronym
MC-studien
Enrollment
85
Registered
2010-06-08
Start date
2010-05-31
Completion date
2013-10-31
Last updated
2015-04-24

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

Conditions

Fractures of the Neck

Keywords

Fracture, 5th metacarpal bone, Bouquet pinning, Fractures of the neck of the 5th metacarpal bone

Brief summary

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.

Interventions

PROCEDUREBouquet 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

Sponsors

University Hospital, Akershus
CollaboratorOTHER
Asker & Baerum Hospital
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quick-DASH6 weeks, 3 months, 1 year, 2 yearsValidated hand function score

Secondary

MeasureTime frameDescription
Pain1 week, 6 weeks, 3 months, 1 year, 2 yearsVAS scale
Eq-5d6 weeks, 3 months, 1 year, 2 yearsValidated quality of life score
Complications1 week, 6 weeks, 3 months, 1 year, 2 yearsAll complications are noted
Patient satisfaction6 weeks, 3 months, 1 year, 2 yearsVAS scale
Range of motion in the joints in the 5th finger measured by hand therapist3 months, 1 year, 2 yearstotal active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
Grip strength3 months, 1 year, 2 yearsCompared to the non-injured hand
Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand6 weeks, 1 year
Sick-leave1 week, 6 weeks, 3 months (1 year, 2 years)Days of sick-leave off work

Countries

Norway

Outcome results

None listed

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