Clinical trial NCT00863473: Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment
Official title: Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Proximal Humeral Fracture
Osteosynthesis or Conservative Treatment
Keywords: Proximal Humerus Fracture in elderly
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2009-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year?
2. Do surgical treatment gain more QALY than conservative treatment after one year?


Eligibility criteria: Inclusion Criteria:

* proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital

Exclusion Criteria:

* aged less than 60 year
* 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

Primary outcomes:
measure: Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).
timeFrame: 12 and 24 months
Secondary outcomes:
measure: QALY (HRQoL score according to Harri Sintonen 15D and Costs)
timeFrame: 12 and 24 months
measure: ASES score (modified self assessment) C) Radiographic score
timeFrame: 12 and 24 months
measure: Radiographic score
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.