Two- Part Proximal Humerus - Conservative vs Operative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorUniversity Hospital, Akershus
About this trial
The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing. The purpose of the project is to compare surgical and conservative management of two- part PHFs in light of radiological, economical and clinical outcome. Do the participants between 60 and 85 years of age with displaced two-part PHFs fare better or worse after surgery compared to non-operative treatment?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients > 60 years and <85 years
More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more than 30˚ varus of the Head Shaft Angle (HSA).
Patient with tuberculum majus or minor fractures which displaced <5mm can be included as long as points 1 and 2 above are fulfilled.
Disqualifiers
Refusal to participate in the study
Fracture more than 3 weeks old
No contact btw head and shaft
Ipsilateral damage that will influence the recovery and scoring systems
Trial design
Design model
Parallel
Treatments tested in this trial
Open reduction internal stabilisation (ORIF)
Procedure/SurgeryTreatment allocated to surgical or non-surgical group. Implant choice pragmatic, surgeons choice.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Non-surgicalNo intervention 0 interventions
Group B: SurgicalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quick Dash
Prom, The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). This is a 100-points scale where 0 is perfect/ best and 100 is the worst possible outcome
Time frame
1 yearSecondary outcomes
1
Constant-Murley score
A clinical method of functional assessment of the shoulder, a 100-points scale composed of a number of individual parameters. \>30 Poor 21-30 Fair 11-20 Good \<11Excellent. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.
Time frame
1 year2
EQ5D
EQ-5D is a standardized instrument for measuring generic health status. The descriptive system element of the EQ-5D questionnaire produces a 5-digit health state profile that represents the level of reported problems on each of the five dimensions in EQ5D. EQ-5D health states may subsequently be converted into a single summary number, which reflects how good or bad a health state is according to the preferences of the general population of a country/region. EQ-5D is designed for self-completion. Further info and List of available value sets for the EQ-5D-3L: https://euroqol.org/docs/EQ-5D-3L-User-Guide.pdf
Time frame
1 year3
Radiology
Radiographs and CT scan before and after surgery, Radiographs of opposite shoulder for comparison
Time frame
1 year4
Number of patients with complications such as infection, Avascular necrosis, failure of osteosynthesis, screw cut out, nerve damage, deep vein thrombosis,
All complications registered; Infection, Avascular necrosis (AVN), osteosynthesis failure, screw cutout, varus of caput humeri, deep vein thrombosis
Time frame
1 yearLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Akershus University HospitalRecruiting0587, Lørenskog, Oslo
Norway
NorwaySponsors and contacts
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Source ClinicalTrials.gov