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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northern Orthopaedic Division, Denmark
Sponsor:
Collaborators:
Viborg Hospital
Vejle Hospital
Randers Regional Hospital
Swemac Orthopaedics ApS
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01078480
First received: February 27, 2010
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention
Displaced Midshaft Fracture of the Collar Bone
Procedure: Operation using a precontoured titanium plate and screws
Procedure: Displaced midshaft fracture of the collar bone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Constant-Murley Score [ Time Frame: 6 weeks, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: April 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm sling treatment
Displaced midshaft fracture of the collar bone treated with an arm sling
Procedure: Displaced midshaft fracture of the collar bone
Displaced midshaft fracture of the collar bone treated with an arm sling
Other Name: No other names.
Experimental: Operation
Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws.
Procedure: Operation using a precontoured titanium plate and screws
Operation using a precontoured titanium plate and screws
Other Name: No other names.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078480

Locations
Denmark
Orthopaedic Division, Randers Hospital Recruiting
Randers, Central Jutland, Denmark, 8930
Contact: Carsten M. Jensen, M.D.    78422136 ext 45    carstjns@rm.dk   
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Viborg Hospital
Vejle Hospital
Randers Regional Hospital
Swemac Orthopaedics ApS
Investigators
Principal Investigator: Carsten M Jensen, M.D.Sci. Orthopaedic Division, Central Jutland, Randers Hospital, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01078480     History of Changes
Other Study ID Numbers: ON-001-CMJ
Study First Received: February 27, 2010
Last Updated: September 12, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Fracture
Collar bone

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014