Skip to main content
OpenTrials
Completed

NCT Number: NCT01078480

Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.

The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Displaced Midshaft Fracture of the Collar Bone Fractures, Bone Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Division, Randers Hospital

Randers, Central Jutland, 8930, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.

Exclusion criteria

  • bilateral fracture
  • imminent skin perforation
  • open fracture
  • associated neurovascular effect
  • unstable fracture of neck of scapula "floating shoulder"
  • fracture of coincidental upper extremity distal for the shoulder
  • pathologic fracture
  • the patient states that there was a unilateral or bilateral shoulder problem before the fracture
  • fracture realized more than 14 days after it arose
  • circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
  • circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
  • medical contraindication against surgery or general anaesthesia
  • former participation in the trial
  • former fracture contra/ipsilateral at the age of 15 or older

Treatment and study plan

Operation using a precontoured titanium plate and screws

Procedure

Operation using a precontoured titanium plate and screws

Other names: No other names.

Displaced midshaft fracture of the collar bone

Procedure

Displaced midshaft fracture of the collar bone treated with an arm sling

Other names: No other names.

Primary outcomes

  1. Disabilities of the Arm, Shoulder and Hand (DASH) Score

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

    The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.

Secondary outcomes

  1. Constant-Murley Score

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

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Collaborators

  • Central Jutland Regional Hospital
  • Randers Regional Hospital
  • Swemac Orthopaedics ApS
  • Vejle Hospital

Registry information

Official study title

Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2010
Registry last updated
Jan 22, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.