Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment
NCT ID: NCT00863473
Last Updated: 2015-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2003-05-31
2010-05-31
Brief Summary
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2. Do surgical treatment gain more QALY than conservative treatment after one year?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conservative /Physiotherapy
Active training protocol with instructed physiotherapy and self excercises
No interventions assigned to this group
Surgery with LCP T plate
Surgical treatment with interlocking plate
Surgical treatment with LCP
Interventions
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Surgical treatment with LCP
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients of non-Scandinavian ethnicity
* previous history of injury or illness of the injured or contralateral shoulder
* injury of other part of the humerus or the contralateral upper extremity,
* alcohol- or drug abuse
* dementia or neurological diseases
* severe cardiovascular disease that would contraindicate surgery
60 Years
85 Years
ALL
No
Sponsors
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University of Oslo
OTHER
University Hospital, Aker
OTHER
Responsible Party
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Tore Fjalestad
MD PhD Consultant
Locations
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Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital
Oslo, , Norway
Countries
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References
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Fjalestad T, Hole MO, Hovden IA, Blucher J, Stromsoe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012 Feb;26(2):98-106. doi: 10.1097/BOT.0b013e31821c2e15.
Fjalestad T, Hole MO, Jorgensen JJ, Stromsoe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury. 2010 Jun;41(6):599-605. doi: 10.1016/j.injury.2009.10.056. Epub 2009 Nov 27.
Fjalestad T, Hole MO. Displaced proximal humeral fractures: operative versus non-operative treatment--a 2-year extension of a randomized controlled trial. Eur J Orthop Surg Traumatol. 2014 Oct;24(7):1067-73. doi: 10.1007/s00590-013-1403-y. Epub 2014 Jan 11.
Other Identifiers
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AkerU_s422
Identifier Type: -
Identifier Source: org_study_id
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