Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone
This study is currently recruiting participants.
Verified May 2013 by Northern Orthopaedic Division, Denmark
Sponsor:
Northern Orthopaedic Division, Denmark
Collaborators:
Viborg Hospital
Vejle Hospital
Randers Region Hospital
Swemac Orthopaedics ApS
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01078480
First received: February 27, 2010
Last updated: May 1, 2013
Last verified: May 2013
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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
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 Moss Jensen, M.D. 78422136 ext 45 carstjns@rm.dk | |
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Viborg Hospital
Vejle Hospital
Randers Region 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: | May 1, 2013 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013