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NCT Number: NCT01139528

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

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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Key information

Conditions

Fractures of the Neck Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, NO-0407, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bouquet pinning of the 5th metacarpal bone

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

Primary outcomes

  1. Quick-DASH

    Time frame: 6 weeks, 3 months, 1 year, 2 years

    Validated hand function score

Secondary outcomes

  1. Patient satisfaction

    Time frame: 6 weeks, 3 months, 1 year, 2 years

    VAS scale

  2. Pain

    Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

    VAS scale

  3. Eq-5d

    Time frame: 6 weeks, 3 months, 1 year, 2 years

    Validated quality of life score

  4. Complications

    Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

    All complications are noted

  5. Sick-leave

    Time frame: 1 week, 6 weeks, 3 months (1 year, 2 years)

    Days of sick-leave off work

  6. Range of motion in the joints in the 5th finger measured by hand therapist

    Time frame: 3 months, 1 year, 2 years

    total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint

  7. Grip strength

    Time frame: 3 months, 1 year, 2 years

    Compared to the non-injured hand

  8. Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand

    Time frame: 6 weeks, 1 year

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Asker & Baerum Hospital
  • University Hospital, Akershus

Registry information

Official study title

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

Acronym: MC-studien

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2010
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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